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Somebody pushed the reset button this past week. Although we don't yet have the weekly variant reports from CDC (they are published on Tuesdays) it is very clear from just my small world at Children's National Hospital that omicron has hit with a vengeance. I was speaking in the hallway on Friday with my longtime friend and esteemed colleague Dr. Larry D'Angelo who likened what we are seeing to the early situation in South Africa where omicron increased exponentially even while delta was still very much present. An important caveat, however: it's risky to make too much out of day-to-day data, many factors affect case rates and sometimes we can be misled by "hot off the presses" numbers.

A Triple Whammy Ahead?

Most winters in pre-pandemic times I kept my fingers crossed that we would not have our RSV and influenza seasons occur concurrently; the few years we had a double whammy like that it really strained our resources. This winter could be worse. The good news is that although RSV is still around it seems to be on a downward trend. However, influenza A numbers have been increasing both at Children's National and nationally, suggesting we will hit full-blown flu season soon. The second and third components of the trifecta are delta and omicron. If we see all 3 of these viruses causing infections in large numbers at the same time it will be very tough. One silver lining of the omicron era is that it may stimulate more individuals to seek out primary series and booster vaccinations. Also, with school winter break and perhaps a bit more caution on the part of the public, we might have less viral circulation the next couple of weeks. We'll see.

For now clinicians should remember we have two effective influenza antiviral medications, oseltamivir (Tamiflu) and baloxivir marboxil (Xofluza), available. From a treatment perspective we don't have a lot of choices for outpatient therapy for pediatric SARS-CoV-2 infections, and the monoclonal antibody combination bamlanivimab and etesivimab just authorized for use down to newborn ages but isn't likely to be effective against omicron. (Note that currently Children's National is not using age under 1 year as an independent risk factor for use of this combination.) NIH has a nice web site to check the latest on effects of different therapeutics for SARS-CoV2 variants, much based on in vitro data rather than solid efficacy studies because it's just too soon in the omicron wave for reliable analysis.

Setback and Hope for Pediatric COVID-19 Management

On December 17 we all learned via a press release that the Pfizer vaccine trial failed to reach the pre-established noninferiority margin for children 2 - 4 years of age, although that goal was reached in the 6 - 23 month old age group. As you know I am an investigator in that trial, at the time of this writing still waiting to hear specific plans for modification of the trial presumably to administer third doses to those children.

Also on December 17, CDC released reports of 2 studies of the "Test to Stay" (TTS) strategy for managing school attendance with positive covid cases, one from Los Angeles County, CA, and the other from Lake County, IL. A lot of us have been waiting for high-quality published data on this approach. The basic approach to TTS is described on the CDC web site, suffice to say ready access to testing must be available as well as compliance with masking and other prevention methods. We of course do not have data available for TTS efficacy in the omicron era but at the moment this seems to be a reasonable approach.

Bottom line for all of this, we are entering another worrisome time for COVID-19, no reason to panic but be careful and stay abreast of new developments. Please encourage everyone to get their influenza and COVID-19 vaccinations, including boosters for the latter.

Well, maybe not dazed, but then I couldn't have a movie reference. Every outbreak manual I know of stresses the importance of clear messaging from authorities. That's been lacking with the booster roll out.

How Can You Follow the Science When It Doesn't Provide Answers?

That's probably the underlying problem brought to light at the recent FDA/VRBAC and ACIP/CDC meetings discussing COVID-19 vaccine booster plans. I commented a bit last week on the first meeting, but the ACIP/CDC meeting and its aftermath really shook things. up. I was able to attend most of the proceedings, especially the meatier parts and the discussions. At the risk of over-simplifying an extremely complex issue, the current data just don't answer the question of whether boosters now will have any great benefit for individuals receiving them or any impact in calming or preventing surges. The only likely benefit is for the "elderly," (yes, it still irks me that I fall into that category) and even that isn't entirely conclusive. Thus we are down to risk/benefit discussions that suggest moving towards the riskier side of the scale at younger ages. My 35-year-old son, also a healthcare provider, received his Pfizer primary series last January. He asked me if I thought he should get a booster and I was able to respond generally yes, with some caveats about potential rare myocarditis risks. As pediatric healthcare providers, the patients asking our advice are likely to be in the 18-25 age range where potential benefits to the individual seem to be very low, so even small risks start to become a consideration. Look at Dr. Thornburg's great explanation of immunity and SARS-CoV-2 as well as Dr. Oliver's presentation, slides 46 and 47 in particular, for a good discussion on risks and benefits for different ages and circumstances.

As for me, about 8 months out from completing my primary Pfizer series, I suppose I will get the booster when it is offered to me, but no big deal if I have to wait a bit. I will be getting my flu vaccine soon.

More School Studies

MMWR published 3 Early Release articles on September 24. They don't necessarily tell us anything new but are important because the all suggest that masks, along with other mitigation strategies, still are highly effective in the delta variant era.

Two of the studies were headed by CDC with help from other institutions. One looked at pediatric COVID-19 cases from July 1 - September 4, 2021, in counties with and without school mask requirements. After the start of the school year, the increase in daily case numbers was much higher in the counties without school mask requirements compared to those with mask requirements. The other study looked at mask use effects on school closures and learning modality changes from August 1 - September 1 and again found evidence in support of mask requirements.

The third study was limited to Maricopa and Pima counties in Arizona and carried out in July and August. These counties comprise 75% of the state's population, and the study concluded that the odds of a school-associated COVID-19 outbreak was 3.5 times higher in schools without a mask requirement compared to those with mask requirements implemented early in the school year which began in July.

All of these studies have significant limitations; it is very difficult to control for all of the potential confounding variables. However, masking requirements in schools, coupled with multi-layered infection control measures, still work extremely well in the delta era. We all need to concentrate on that, as well as trying to vaccinate the unvaccinated.