Skip to content

I feel a bit on the cusp of important news in the next few weeks. How much fallout will we have from the Labor Day holiday, resumption of football and other sports with variable COVID-19 mitigation strategies in place, and of course school openings? What will the FDA say about booster vaccine doses at their meeting on September 17? Will Pfizer submit data on vaccines for 5-11 year olds this month? By October we could be in a new era of the pandemic in the US.

Testing Asymptomatic Children in Schools

This is an important component of infection control in schools, in combination with vaccination of all eligible individuals, distancing of at least 3 feet between desks, contact tracing, air quality measures, and quarantine/isolation policies. None of these measures alone is likely to be effective without the full package in use.

A story in the September 12 Washington Post caught my eye, mentioning that 24 of 4109 asymptomatic children tested by DC public schools was positive for SARS-CoV 2. That's a rate of 0.6%. Keep in mind that, no matter how good the test is, with a prevalence that low even a highly specific test showing a positive result might still be more likely to represent a false positive than a true positive. I'm all for more testing in schools, just be warned about the difficulties in interpreting results for individual children.

New Therapies for COVID-19 Disease

I have the sense that the lay press isn't reporting a whole lot about this. Ivermectin does seem to get a lot of publicity, I still don't understand how it became so popular, but evidence to date suggests that this medication is an ineffective treatment. The better-designed studies suggest no benefit, but certainly we could still use some larger randomized controlled trials to help determine if there is a use for the drug. In vitro studies suggest it may have some antiviral effects, but in concentrations likely to be toxic to humans. It also has some anti-inflammatory characteristics that might be beneficial. It's not a particularly dangerous drug as long as you don't use the horse dosage!

I'm intrigued with early studies of fluvoxamine, an SSRI medication mostly useful for OCD and some related disorders. I'm waiting to see more data and would not at all recommend using this for infected children at this time. You might be interested in the TOGETHER trial, an adaptive design trial based at McMaster University and still ongoing. One pre-print (non-peer reviewed) study suggesting benefit of fluvoxamine in one setting is a good example.

I couldn't help thinking, as I channel-surfed through various college football, golf, and other sporting events on Saturday, that COVID-19 disease rates will see another significant spike in the coming weeks. I hope I'm wrong. Hand-wringing aside, I wanted to mention a couple issues that you might have missed this past week.

MISC-C Long-term Followup

I fall into the glass half full crowd when I read this report on 1 year follow-up data for 68 children in England. No deaths occurred and only 2 children required critical care readmission. Fourteen of 19 children with coronary aneurysms had resolution and all 39 with abnormal function but no aneurysms had returned to normal echocardiograms. Yes, I know it's just a few patients, but given how sick most of these kids are at the start I'm encouraged.

The Rule of 3's

This month could see data submitted to FDA requesting authorization for COVID-19 vaccines for children under 12 years of age. Because these trials are "immunobridging" studies, the key data in addition to safety are whether the immunologic responses are similar to those seen in adolescents and young adults who showed protection from infection in the larger efficacy trials.

Speaking of safety, you all have probably heard that FDA requested additional children ages 5 through 11 years to be enrolled in the mRNA trials. I was puzzled by this because the myopericarditis rates seen so far are pretty low, about 10 excess cases per million vaccine doses in a recent article. It would require an impossibly large number of children in a research trial to detect this, so I was even more surprised to hear FDA's Peter Marks state that the FDA was following the rule of 3's in trying to assess safety of these vaccines for serious adverse events. This rule is explained in an oldie but goodie review article in JAMA stating that, if no events occurred in n subjects we can be 95% confident that the highest chance of this event is 3/n. The number of subjects in these current trials are in the few thousands, so if the logic behind adding a few more is to satisfy cardiac inflammatory risk concerns the addition of a couple thousand more subjects probably won't answer the question. It may allow some reassurance that the rate isn't substantially higher than what is being seen in adolescents and young adults.

This song (as covered by The Happenings in 1966) has always stuck with me. September is upon us and schools are opening across the country. This year, however, these openings bring a bit more fear and arguments than in past years.

Another Lesson on Mitigation in Schools

Many of you likely have heard about the outbreak in an elementary school classroom in California reported in an early release from the CDC on August 27. The setting was an unvaccinated teacher who otherwise was following all the rules and teaching in a classroom that was optimized for prevention of SARS-CoV-2 transmission. The teacher became symptomatic but kept working plus routinely took his/her mask off to read aloud to students in class. What happened next is well summarized in this diagram from the report.

Note that the desks are 6 feet apart, an air filter was at the front of the room, the door was kept open, and windows flanking 2 sides of the classroom were open. The distribution and timing of cases in the classroom strongly suggest the teacher was the source of infection at least at the start of the classroom spread.

Vaccination, masks, social distancing, and other mitigation strategies all are important to keeping our kids safe when school opens.

Weighing Vaccine Risk/Benefits for Younger Children

Michael Schwartz, a former CNH pediatric resident and 1 of only 3 people (my wife and 1 of my 3 sons are the others) that I know actually read this blog, asked a great question last week that I wanted to answer more prominently this week. The folks at CDC have been great about distilling risks and benefits of the COVID vaccines as various rare adverse events have come to light in adolescents and adults, but do we have equivalent data for younger children to weigh the risks/benefits if and when vaccines are authorized for younger age groups?

I'm pretty sure CDC has access to unpublished numbers that they are monitoring, but for us regular pediatric healthcare providers I think the best place for summaries of pediatric information is the AAP/Children's Hospital Association biweekly reports. At the last update on August 19, things of course aren't looking good. It will be interesting to see how this changes as more schools are back in session. Also, remember that these data summaries are only as good as the sources. For example, the state of Texas (my place of birth, I'm sorry to say) has quit reporting COVID-19 data as of July 22.

Well, not really slow in terms of the rise in COVID-19 cases, now with daily averages in the same range as last winter. But, I didn't see any groundbreaking studies released in the past week that you need to digest immediately. I did find a couple items that should interest you, however.

Vaccine Provides Better Protection Than Natural Immunity Against Reinfection

I was particularly interested in this MMWR report because one of my colleagues had contacted me about his family member a while back. The family member, who had a medical background, was using the fact that he had SARS-CoV-2 infection in the past as a reason to forego vaccination now. He felt he was already protected well enough, and my colleague was unable to convince him otherwise.

We certainly know that vaccination is less effective at preventing infection with the delta variant but still highly effective against developing severe disease. The recent MMWR report goes a step further, giving us pretty good evidence that immunization is better than immunity from natural infection at protecting from reinfection. If you know of anyone using prior infection as an argument against receiving vaccine, maybe you can steer them to this information.

Helping the Public Understand Variants

This is a tough order. The vast majority of us, yours truly included, are not practicing molecular virologists. The CDC just posted a video comparing variants to tree branches. Most of us learn better from graphical or pictorial displays of information rather than endless tables of numbers. See what you think of this 89 second video; recommend it to your patients, friends, and family members if you think it would help.

More data became available this past week, and I think it is safe to say the delta variant is different enough that we will need to modify pandemic practices as the CDC has begun to do.

[Also, on a lighter note, I decided to investigate where the idiom in my title originated. As best I can tell, the first appearance in print was the March 13, 1971 issue of The New Yorker (page 30) in an unattributed posting in the "Talk of the Town" section commenting on what would happen if China entered the Vietnam War. The term appeared in quotation marks and I suspect that was a nod to the fact that the term was already in use.]

Delta Data

The CDC annoyed me early in the week when they came out with new recommendations for masking and other practices, referencing internal/unpublished data but not providing it. Subsequently the Washington Post released a draft slide set from the CDC that I read but was not going to comment on that because it was clearly a draft document. You can look at it but your time is better served by going to the CDC/IDSA COVID-19 Clinician Calls site where CDC's Dr. Tom Brooks provided an overview on Saturday July 31 (presentation not yet posted as of August 1).

Here's the bottom line on what's new and serious about the delta variant. A multisite outbreak on July 4 in Barnstable County, MA is showing us that not only is the delta variant highly contagious but also that vaccinated individuals had similar cycle threshold values to unvaccinated people. Cycle thresholds are sort of a biomarker for amount of virus in nasal secretions, though it is clearly not as reliable as, for example, viral load in blood in HIV patients. Cycle threshold also does not provide any exact translation into amount of viable intact virus present. Still, the concern is that even vaccinated individuals have significant amounts of replicating virus that they can pass on to other individuals and also are themselves a source of new variants. Another, non-peer reviewed, study suggests that the period of contagion with delta may be longer than with the original strain or earlier variants, though less so for vaccinated people. This could mean that quarantine periods after delta infection will need to be extended beyond our current guidelines. We need follow-up studies, but this early information is very sobering.

Note that we continue to see new, encouraging data that vaccination is still incredibly effective against infection (though slightly less so for delta variant) and for protection against hospitalizations and death. The mRNA vaccines are still working far better than anyone hoped to predict a year ago. (We don't yet have enough information about Janssen/Johnson & Johnson vaccine with delta, it hasn't been authorized as long so not as many people in the US have received it.)

Pandemic Communication

My whining about CDC being less than transparent and straightforward this week leads me to mention that CDC (and also WHO) has had a panoply of pandemic playbooks available well before the current pandemic, with a lot of updating following our 2009 influenza A pandemic (remember that?). I decided to browse the CDC's 2014 Crisis and Emergency Risk Communication Manual. At 462 pages it is not for the faint of heart, but it was interesting to reflect on communication with the current pandemic. In my nonexpert opinion, I would say that early in the pandemic it seems as if no one had even consulted this manual. Lately things are better, but the CDC needs to provide timely, clear updates and provide the supporting data at the same time so that the rest of us can make our own assessments. This is a tough job, no doubt, but I'm hoping they are learning quickly how best to manage public information in these very difficult times.