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Published on Leave a comment on Try to See It From Grendel’s Perspective

Ever read Beowulf? Me neither. Nor do I plan to ever read this epic poem consisting of 3182 lines of alliterative verse. Recently I did read Grendel by John Gardner. Grendel is the monster who was killed by Beowulf in the famous poem. Gardner's book is told entirely from Grendel's perspective, very different from how Beowulf and the other humans saw things of course.

Malaria Season

Practicing in the Washington, DC, area for almost 40 years meant that I had a steady diet of malaria. Our "malaria season" was towards the end of summer when vacationing families returned home after visiting relatives in malaria-endemic countries. This seasonality abated a bit during the pandemic when international travel was scarce, then came back with a vengeance. Now, however, autochthonous malaria has been reported in Florida and Texas.

Autochthonous, from the Greek autokhthon meaning "sprung from the land itself," in this instance refers to malaria acquired without visiting a malaria-endemic country. I didn't mention the initial CDC report a couple weeks ago, but now that a second state is involved and CDC issued a health alert advisory, I'll attempt to summarize what's happening.

We still have virtually no clinical details about any of the 5 cases, but CDC implied they are all due to Plasmodium vivax which is not as severe/deadly as P. falciparum. Autochthonous malaria in the US was common in the old days, but since effective mosquito control programs in the 1950s it has been scarce. Prior to the current reports, we hadn't seen autochthonous malaria since 2003. High risk areas in the US are those that have high population density, plenty of Anopheles mosquitoes (including favorable conditions for their reproduction), and a source of people who have recently traveled from malaria-endemic areas. So, it's not surprising that Florida and Texas are points of origin now.

Speaking of mosquitoes, climate change has greatly increased the range of various insect vectors of disease; for example, Lyme disease risk has expanded geographically in recent years as deer ticks broaden their range. Anopheles mosquitoes are present in virtually the entire US.

For frontline providers, malaria shouldn't be the first thing to suspect in a child with fever in the US, but recognize that in cases of prolonged fever it is a consideration even without a history of international travel. Look at the CDC's malaria website for more details, and read this article if you want to see a longer discussion of (prepandemic) autochthonous malaria.

Foodborne Disease is Back

Another sign that the pandemic is lifting is this CDC report of 2022 data. Certain foodborne illnesses such as Shiga toxin-producing Escherichia coli, Yersinia, Vibrio, and Cyclospora infections increased compared to 2016–2018 data; Campylobacter, Salmonella, Shigella, and Listeria incidences didn't change much. Although they didn't show the data in this report, foodborne diseases decreased in the 2020-2021 time period.

I was a bit disappointed that, although the report did mention increased use of culture-independent diagnostic testing rather than culture, it did not mention the fact that the highly sensitive CIDT methods can be more prone to false positives. This makes it difficult to compare trends across time periods.

Ideally one would perform a backup culture test for bacterial pathogens particularly to detect antimicrobial resistance; CIDT can not test for this.

Can We Shorten Treatment Duration for Pediatric Urinary Tract Infection?

The short answer is yes, but the more difficult question is how to decide which patients are appropriate for shortened therapy. Even this randomized controlled trial couldn't answer that question. The study compared 5 versus 10 days of therapy for UTI in children 2 months to 10 years of age. Children who showed clinical improvement at 5 days treatment were then randomized to another 5 days of antibiotic versus placebo. Failure rate in the 10-day treatment group was 0.6% versus 4.2% in the 5-day group.

Ultimately I think the details of study design doomed this trial to leave this question mostly unanswered. In particular the duration of followup after stopping antibiotic was too short for the 10-day group (which would have skewed results to a falsely low failure rate). Fundamentally the problem with UTI treatment in children is trying to determine which children have pyelonephritis versus just cystitis, much more difficult in children than in adults. Pyelonephritis likely requires more than 5 days of treatment.

This study definitely adds to our understanding of pediatric UTI but I don't think is immediately transferrable to clinical practice. The accompanying editorial offers some ideas in this regard.

'Demic Doldrums

We continue to enjoy relief from covid from the standpoint of no evidence of major surges around the world, just continued pockets of upswings in disease activity (tempered by the knowledge that we aren't tracking it very well now). Of course, the number of total cases in this WHO graph, as of June 28, is pretty depressing overall.

According to WHO, confirmed covid deaths now number 6,947,192.

Blood Group and Covid

I have blood group A positive. Should I be worried? It's been known for a while that individuals with type A blood have a slightly higher risk of SARS-CoV-2 infection, and this recent article lends some credence to these observations by supplying a biologic explanation. The A blood group antigen is very attractive to the receptor binding domain of the virus, including omicron variants. But no, I'm not concerned. The increase in infection risk attributable to blood group is very small, paling in comparison to other risk factors.

Whatever Happened to Wastewater Monitoring?

In the US, wastewater monitoring for viruses like SARS-CoV-2 has great potential but is ineffective because it involves voluntary reporting by states. Most people in the US live in areas that don't monitor wastewater. Our northern neighbors in Canada, specifically Peel, Ontario, provide evidence that wastewater monitoring truly can be an early warning for increased infections. Investigators reported that wastewater levels predicted very reliably 1 day before the rise in infections and 4 days before a rise in hospitalizations during the omicron period of November 2021 to June 2022. At this point I'm not sure if the US has the resources to implement wastewater virus monitoring on a larger scale.

Better Evidence for MIS-C Treatment

The multi-system inflammatory syndrome in children is still difficult to diagnose precisely. Thankfully MIS-C seems less common in today's covid era with omicron dominance and high levels of antibody in the population. Now we have some better guidance for immunomodulatory therapy for MIS-C. This meta-analysis suggests that the combination of intravenous immunoglobulin plus glucocorticoid therapy improved cardiovascular dysfunction better than either agent alone. The study was very well done but had to rely heavily on nonrandomized cohort studies which introduces a great degree of bias in the results. We missed a chance by not conducting large RCTs of MIS-C treatment early in the pandemic.

Understanding Grendel

I needed to consult Wikipedia and other Cliff Notes-like versions of Beowulf to understand Gardner's book. As with everything I read, I think about what, if anything, might apply to me. With Grendel and Beowulf it was relatively easy. When faced with dramatically different perspectives, say for example pandemic deniers or anti-vaxxers (Grendel) versus traditional science and medicine (Beowulf), it's a good idea to try to see things from the opposing perspective. If one can do this without resorting to raised voices or worse, it's possible to have a meaningful dialog and even occasionally change minds, even my own! Next time you see me, look for Grendel perched on my shoulder. For those less prone to wild fantasies I recognize this is quite a stretch, but regular readers are accustomed to my tangents.

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.

Published on Leave a comment on What Next?

We are definitely in a new era now. If you need evidence of that, just look at CDC's most recent listserv message:

For the future, look to the CDC's revised covid data tracking site:

What's mainly missing are the covid community levels. Combined with the knowledge that all jurisdictions have stepped down their level of disease monitoring resulting in significantly fewer data points means we aren't anywhere near the level of infection tracking we had previously, though even that varied with jurisdiction. Wastewater monitoring is likely to be the most reliable early warning of a resurgence in the US, but note that this monitoring is done on a voluntary basis, covering about 40% of the US population but very skewed geographically. Here's the latest CDC wastewater map looking at variant analysis:

Increasingly I will be turning to the World Health Organization to look at what's going on elsewhere. Current "hot spots" include the SE Asia and Western Pacific regions.

I was also reminded of changes more locally for me. My phone told me this week that I would no longer receive notifications from Virginia's COVIDWISE app to tell me if I had been exposed to anyone with covid. Since I never received any notifications anyway, I wonder how effective it was. I probably set it up incorrectly.

My Book Report - Preliminary Thoughts

As promised last week, I've been working on my first book report since elementary school. However, when I took a break to actually find out what a book report is, I'd say what I've done is more like a book review. The book is Lessons from the Covid War,: An Investigative Report, ISBN-10 1541703804, authored by "The Covid Crisis Group" but principally written by University of Virginia history professor Philip Zelikow. I picked up my copy on April 27 and took my time reading it. I wanted both to see what they had to say but also to determine potential sources of bias in the report. The Crisis Group compiled the report given that there is still no federal commission planned to officially dissect the pandemic response. I purposely haven't read other reviews of the book, though I recall from one TV news report that the reviewer felt they were too soft on criticizing the Trump administration.

First, let's drill down on the potential sources of bias, particularly important with a highly charged political topic. Dr. Zelikow certainly is well qualified for the project having served as executive director of the federal 9/11 Commission. He has held several jobs in both Democratic and Republican administrations. The other 33 members of the crisis group include some involved in politics (again from both sides of the aisle) as well as physicians, scientists, and public health specialists. Notably missing from the group was anyone heading the response from either the Trump or Biden administrations, perhaps a good thing though leaving a gap in verifying circumstances or allowing rebuttal. The report itself has a thorough listing of individual and organizational sources of interviews and other materials, as well as 25 pages of fine-print notes for specific statements in the text.

Another potential source of bias is funding source. Four foundations sponsored the group: Schmidt Futures, the Rockefeller Foundation, the Skoll Foundation, and Stand Together. After reviewing their web sites and other commentaries, my best guess is that 3 are slightly left-leaning and 1 is tilted more towards the conservative side. All have excellent records of interest and accomplishments in various international efforts including disaster evaluation and relief. The foundations contributed equal funds and had no role in drafting or writing the report.

So, my final gestalt is that this is about as non-biased a report as can be expected for the topic. I think the only people who could conceivably have major concerns with it would be those who do not accept the scientific method or specific source documentation.

The report itself is well-written, with explanations making it accessible to those without a scientific or medical background. I was a little put-off by the near constant comparisons to war and military strategies, although the comparison of Operation Warp Speed for vaccine development to the 1940s Manhattan Project to develop the atomic bomb was convincing.

The Meat of the Report

Here are some of the points I thought were helpful.

Clearly the Group felt that we were doomed in our response from the start by the state of our public health system in the US, little changed from the late 19th century in their opinion. They describe 3 main cultures in governance: program and process, research and investigation, and operations. We were lacking in all 3 prior to the pandemic, resulting in much higher loss of life and interruption of daily activities than would have occurred if we had invested in this infrastructure previously. They allude to investing billions to save trillions, and this principle still holds.

I learned that the "Communicable Disease Center," precursor of the CDC, wasn't established until 1946. Atlanta supposedly was chosen as the site because more malaria was present in the South, though this tidbit didn't have a footnote so I'm not sure if that is accurate. The Group clearly feels that the decentralization of public health (we have 2800 local public health departments varying widely in expertise, technology access, and operational guidance) needs overhaul in order to have an effective response to wide-scale emergencies. Essentially, we do not have a national public health service, "all operational responsibility [is] at the state, local, territorial, and tribal levels." (page 71).

I somehow missed or didn't remember that the White House Council of Economic Advisors issued a report in September 2019 estimating that a pandemic would cost trillions and kill more than 500,000 people in the US. It was based more on influenza and sadly turned out to be an underestimate. I was also unaware of Crimson Contagion, a pandemic exercise conducted in early 2019 that identified many coordination problems in responding to an influenza-like pandemic. The death toll in the exercise was in the hundreds of thousands.

Regardless of our preparedness prior to the pandemic, it is clear that our responses once it started contributed to greater hardship and loss of life. Early in 2020, so many mistakes were made it would almost be comic without the tragic results. Virtually everyone in the US failed to realize key differences between an influenza pandemic and covid (or coronaviruses in general). These include the presence of asymptomatic infection with effective human transmission from those individuals, the nature of aerosol spread and use of mask, social distancing, etc., the ability of the virus to rapidly produce variants resulting in multiple disease waves, poor development and deployment of resources and distribution systems, and, critically, effective communications.

Operation Warp Speed is one of the few successes of the US response. Prior to reading this report, I had credited the government of China with posting the genomic sequence of the virus early in January, 2020, but I learned that the sequence was posted by a Chinese scientist without government permission. This sequence was a necessary precursor for covid vaccine and test research. Thankfully, investment in basic research in coronaviruses and mRNA technology allowed for a rapid response to produce effective vaccines in record time. Still, we failed miserably in vaccine distribution and communications about benefits and risks to the general public.

Needless to say, it is the communication issues where the Trump administration, the president in particular, derailed effective vaccine uptake early on and continues to contribute to the anti-vax movement and almost total covid vaccine refusal in some groups. Any chance at herd immunity was lost fairly early in the pandemic. In April and May 2020 "Trump poured acid on the strained bonds" (p. 209) trying to hold together all the different parts of the US pandemic response, effectively eroding trust and confidence in public health.

The US also did not have a system to detect variants quickly. Instead, we relied on Israel, Denmark, the United Kingdom, and later South Africa to give us early warning. The Report also is critical of President Biden and his administration, especially in 2021; no one gets off cleanly.

The good guys for pandemic response globally appear to be South Korea and Germany; the Group implies we can learn a great deal from them.

It isn't until page 253 of the 288-page Report that we start to see concrete considerations for going forward. As you might expect, it takes money, authorized by Congress on a multi-year basis, to start to prepare for the next pandemic. This holds whether it be covid, another coronavirus, influenza, or something we haven't yet identified. We also need to partner globally; we've all seen how closely tied together we are with fellow world citizens, not only with pandemics but with localized outbreaks (remember Ebola?) that can spill into other parts of the world very easily. Today, the Middle East has no covid vaccine manufacturing sites. Sub-Saharan Africa has only one. Abandoning the World Health Organization and adopting the America First strategy early in the Trump Administration really hurt the pandemic response.

I counted 13 different lessons from the final chapter. (I was disappointed that the Report was almost devoid of tables and graphs, so I made my own.)

  1. Develop systems to govern highly risky biologic research
  2. Build worldwide early warning systems for early threats
  3. Develop systems for ongoing evidence gathering during a crisis
  4. Develop basic vaccine designs for each category of potential pandemic agents and create vaccine libraries with resources to manufacture and distribute vaccines at high scale
  5. Plan similarly for development, distribution, and use of diagnostic tests
  6. Ditto for therapeutics
  7. Advance investment and access to emergency funding
  8. Plan for proactive partnerships with private industry to meet public needs
  9. Create effective global coalitions
  10. Develop effective non-medical interventions to buy time early in health emergencies
  11. Crisis communication - need I say more?
  12. Develop a "coherent national health security enterprise" (p. 284)
  13. Perhaps not a separate point, but I think very important. The White House should not be the center of crisis management (corollary: the President is not the central guide for large operation management); we need a new structure as in #12.

I realize I've now detailed only about 1/3 of the underlinings, highlights, and margin notes I made in my copy of the Report. I won't bore you with all that. Suffice to say that I highly recommend reading this Report if you want a better understanding of the US role in the pandemic. It's certainly not the final word, but I hope Congress and high-ranking officials in the federal government pay attention to it.

And, to be fair, it's not like the feds are doing nothing. As I mentioned last week, CDC has a planned overhaul, though maybe at risk with a change in leadership. HHS just announced a new plan. FDA is trying to evolve based on pandemic lessons learned. All we need now is political consensus and funding!

Thanks for putting up with my long-winded book report/review. Now I can dig into "Maigret in Retirement."

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Published on 2 Comments on (Try to) Keep It Simple

I had high hopes that the relative lull in covid disease would allow me to focus on other topics in this blog, but my wishes took a setback this past week mostly due to FDA and ACIP weighing in on simpler covid vaccine recommendations. While it is true they are simpler, as usual there is much complexity in the details.

The New Covid Vaccine Guidance

I was wondering what was taking so long for the FDA to update recommendations particularly for spring boosters for "elderly" (how I hate this word!) and immunocompromised individuals. Most of those individuals are several months past their last vaccine doses, and most studies show significant waning of protection after about 3 months. Well, it turns out they may have been waiting for the next regularly scheduled meeting of the ACIP on April 19, because they released their simplified authorization for bivalent vaccines on April 18. Both agencies recognize the need for simplicity if we are to see any improvement in the horrific vaccination rates in our country.

Still, lots of questions remain. I tuned in to the ACIP meeting, let's look at some highlights of their presentation.

To summarize a large amount of data, vaccine safety signals continue to be very encouraging. Separately, a new publication in Pediatrics showed a lower rate of vaccine-associated myocarditis in adolescents than had been reported previously, using data from the VAERs system.

No matter what angle you use to look at the data, the benefits of vaccination clearly outweigh risks even in the present day where most of the US population have some degree of immunity from prior infection, vaccination, or both. Here are the latest pediatric antibody data:

Looking and listening to the early presentations, I was most struck at the very effective safety tracking systems in place, composed of both old and new methods of safety assessment.

It's important to recognize that each of these systems involves different methodologies and looks at different aspects of safety. I was eligible for and received my second bivalent booster last Friday. (I should note, I'm considered "elderly" in the US in terms of this bivalent booster, but not in the UK where apparently age 75 is elderly and I couldn't have received a booster!) After my injection, I decided to look into v-safe again. I'm glad to say that v-safe is still operational and thus I was able to report on my symptoms, which were none. Those of you who have used v-safe in the past, as I have done for all 6 of my own covid vaccines, know that it asks about specific, common, side effects. It's great to monitor those rates, but it isn't a system that is designed to catch rare side effects of the vaccine. Other systems do that quite well, however, though still tough because we're talking about such extremely rare events that may occur at similar rates in the general/unvaccinated population.

Dr. Ruth Link-Geddes presented data on vaccine effectiveness against symptomatic infection in young children, collected through the ICATT (Increasing Community Access to Testing) system. VE is a difficult and somewhat moving target since vaccine uptake is so low in this population, it might vary with brand of vaccine and time since last vaccination, and, as usual, the variants are changing. As you can see, the data are very current.

Note that the Pfizer primary series requires 3 doses versus 2 for Moderna, and the system had too few children who received 3 Pfizer doses to break down VE further to give an estimate of how/when protection wanes.

A nice simplification for practices administering covid vaccines is the decrease in types and appearances of vials needed:

Now for the complicated details. It was clear that not all scenarios have been addressed, especially for the pediatric population. One such messy detail is the difference in age cutoffs between Moderna and Pfizer vaccines, with a transition at the 6th birthday for Moderna and the 5th birthday for Pfizer. As Dr. Sarah Long brought up in the ACIP meeting, there's not much difference immunologically in the 4 - 6 year old age group, but currently we are stuck with confusing guidance simply because the 2 companies chose different age breakdowns for their clinical trials. The FDA needs to get past this.

Also, it was very clear that ACIP (and FDA) have said nothing about spring bivalent boosters for severely immunocompromised young children such as transplant recipients. As it stands now, they have no option to receive another vaccine until perhaps fall 2023, yet they are among the most vulnerable populations. We don't have results from studies in this population, but that's not a compelling reason to hold off making a recommendation for the interim period. Perhaps other organizations (American Academy of Pediatrics, et al) need to press FDA and ACIP on this matter.

Another gap in the new guidance is what to do about healthcare providers. It seems like eons ago, but HCP were given priority in the initial vaccine rollout as a means to provide some protection to vulnerable populations and also try to preserve HCP availability to provide care during peak pandemic disease periods. It is perhaps not as crucial now, but given that some are calling for removal of universal masking in healthcare settings, how about considering a system of choosing either masking or another booster for those HCP? Masking in general isn't a big deal for most, but it is another expense and we do need to be cognizant that it does interfere with communication, especially for those whom English isn't their primary language or for those with hearing impairment and other disabilities.

CDC has updated their web page with these changes, though it's a load of words and tables that make it very tough to get the picture quickly. I"m hoping they come up with a more graphical decision aid soon. Also, a COCA call webinar to explain all this to HCP is planned for May 11, though the listing is not yet posted on their website.

Statewide Variation in Covid Policies

An article from The Lancet caught my eye. It is based on database analysis and funded by organizations mostly supporting vaccination and other public health preventive measures so must be taken with a grain of salt. However, it did demonstrate that "State governments' uses of protective mandates were associated with lower infection rates, as were mask use, lower mobility, and higher vaccination rate, while vaccination rates were associated with lower death rates." Gross domestic productivity and reading test scores were not associated with state policies, but lower 4th grade math test scores were associated in some settings.

A New Approach to Antibody Treatment

We have been through the whiplash of having effective monoclonal antibody treatments available at different times during the pandemic, only to see them rendered useless when a new variant takes over. Much research is ongoing to find a better way, and one might be the use of recombinant polyclonal antibody treatment as mentioned in this article from a California company. It's just an in vitro article, a long way from efficacy trials, but expect to see more about this approach.

Those Pesky Variants

Speaking of variants, the XBB sublineage has taken over in the US according to CDC data, and that XBB.1.16 strain that I mentioned had grown dramatically in India is now projected to have some advantage in both the US and the UK. It appears to be very agile with immune escape, but not much data yet on severity of disease. XBB.1.16 is the dark blue at the bottom of the vertical bars below.

The Simple Life

Once again I fell into the trap of being led from contemporary entertainment to the book on which it was based. This time it's the Richard Russo novel, Straight Man, on which the AMC series "Lucky Hank" is (somewhat loosely) based. I've only seen 2 or 3 of the TV episodes, but the book highlights Occam's Razor. I've used this reasoning aid in my clinical diagnosis thought process for years, even before I knew about its existence. It's been badly misquoted and misused, including in the Russo novel, but it does focus on simplicity. I loved that Russo's protagonist's dog is named Occam. I haven't yet finished the book but I am enjoying it - a humorous, sarcastic take on life in academia, some of which I've unhappily experienced.

Published on Leave a comment on A Spring in My Step

Both the springtime weather and a recent visit with family that included my granddaughter definitely put a spring in my step. Also useful for lawn mowing duties that have hit peak April duty.

A Worrisome Outbreak

Public health authorities recently called attention to an outbreak of hepatitis A associated with frozen organic strawberries sold on the west coast. That's not particularly unusual news. What really caught my attention was the fact that the strain of hepatitis A causing disease this month is identical to a strain that caused an outbreak in 2022. In essence, the cause of a past outbreak was identified, but whatever measures were taken to stop the outbreak didn't prevent the current one.

The FDA first warned of the current outbreak in February 2023, but an April 11 update (scroll to bottom of the page) identified the strain as being the same as last year's outbreak; the supplier is in Baja California. Multiple retailers had offered the products for sale, including big name stores such as Costco, Aldi, and Trader Joe's.

Currently only 7 infected individuals in 2 states have been identified, but this is always an underestimate since many people with hepatitis A never receive testing.

Those of you not residing on the west coast shouldn't feel entirely safe. The 2022 outbreak spread to the midwest, and the strawberry products in the current outbreak have been distributed nationwide. The products have been voluntarily recalled, but some families may have these contaminated strawberries in their freezers. Families can learn brands and lot numbers at the FDA link above.

Fauci's 10 Lessons

Dr. Fauci and his former chief of staff at NIH, Gregory K. Folkers, published a perspective article covering their top 10 lessons learned from the COVID-19 pandemic that may be useful in further pandemic planning. It's not anything particularly new or startling but nice to see gathered in one place. I was particularly struck by #1 ("Expect the unexpected.") and #10 ("Emerging infections are forever."). Given our current state of public health disarray in the US, I feel like we are sitting ducks for the next one. The tremendous culture wars surrounding personal freedoms combined with the strong resurgence of the anti-vaccination movement could greatly interfere with controlling the next epidemic or pandemic.

Infectious Period and Transmission of the Omicron Variant

The Health Security Agency in the United Kingdom published a great review of data regarding the omicron variant, covering the period from the start of the omicron wave in December 2021 through January 2023. It's a 54-page document, but fortunately you can read a nice summary of the main messages at the start.

Regarding the infectious period, most transmissions from symptomatic individuals occur during the first 5 days of symptoms. Similarly, peak viral loads occurred 2 to 5 days after symptom onset. Viral clearance mostly appeared on days 7 to 11 in the general population and slightly longer in more severely ill or immunocompromised groups (10 to 15 days).

Studies comparing viral loads and transmission rates from symptomatic versus asymptomatic people were mixed. The Agency could not make any firm conclusions from the studies comparing these 2 populations.

This review should be helpful as various groups try to decide on rational quarantine and school attendance policies for the near future.

Sitting Ducks

Although I grew up in south Texas in the 1950s and 60s and knew many hunters, I don't know a thing about duck hunting. The idiom "sitting ducks" that I used in the Fauci section above must come from a hunting analogy, but I was stymied in trying to pin down an accurate origin for the term; clearly it was in use during World War II. I did learn a bit about uropygial, or preen, glands that produce oil and help maintain duck buoyancy, can't wait to bring that up at my next group gathering.

In the meantime, get out and enjoy the springtime!

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