COVID-19 vaccine – Page 19 – Pediatric Infection Connection

See You in September

Bud WiedermannAugust 29, 2021Leave a comment

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I'm pretty sure CDC has access to unpublished numbers that they are monitoring, but for us regular pediatric healthcare providers I think the best place for summaries of pediatric information is the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.

Another Week of Confusion 1

Bud WiedermannAugust 22, 20211 Comment

The COVID-19 pandemic is confusing at baseline, but now others who should know better are aggravating the situation. My post this week is a little verbose, I'll try to return to concision next week.

To Boost or Not to Boost, That is (Not) the Question

Most evidence points to a need for a booster vaccine dose for the mRNA vaccines, but the timing is far from clear. So, I was dismayed to see that the main message this week was that everyone (some more than others) needs a booster 8 months following completion of the 2-dose series. Buried in the pronouncements was the fact that FDA and ACIP will look closely at the data to make a judgment. It is absolutely appropriate to plan for the possibility that booster vaccine doses will be administered in September, but don't use the need for advanced distribution planning as a surrogate for an 8-month booster timing. Let FDA and ACIP do their jobs.

I say this after having gone over the evidence with my best fine-tooth comb. Three reports appeared as early releases August 18 in MMWR. All are well-designed and well-reported studies utilizing different databases and study designs. One looked at hospitalizations in New York state from early May to late July, another at duration of effectiveness of mRNA vaccines March through July throughout the country, and the third (and only CDC study) looked at vaccine effectiveness in US nursing home residents March through July. The most important take-home point from all 3 studies is that the mRNA vaccines are all still tremendously effective at preventing severe illness and death. (The Janssen/J&J vaccine hasn't been in use long enough to make any concrete conclusions about changes in efficacy.) There was a slight decline in effectiveness in some groups recently, but whether this is due to waning of vaccine immunity, the appearance of the delta variant, or both isn't possible to sort out yet.

What really has had the steam coming out of my ears lately is the discussion of Israeli data, as yet unpublished in a peer-reviewed journal. It seemed to me to be a clear error in statistical analysis and reporting, something I would use an example in my old EBM classes. Just this week I found support in the form of an online site that explains the problem far better than I could. It is an example of Simpson's Paradox (Edward Hugh Simpson, not Homer). Briefly stated, Simpson's Paradox is "a trend or result that is present when data is put into groups that reverses or disappears when the data is combined." More simply, if one is not careful to take into account confounding variables, you can end up with conclusions that are the exact opposite of the truth. In the case of the Israeli data, reanalyzing numbers available from the Israeli government data dashboard showed that it is likely that claims of waning vaccine efficacy are a byproduct of higher vaccination rates in the elderly, who have more underlying risk factors, compared to the highly unvaccinated group of teenagers and young adults. When you correct for the confounding, or hidden, variables, the vaccine efficacy looks great for all ages.

Please Don't Administer Vaccines Off-Label!

I received an email from the mother of a child enrolled in our COVID-19 vaccine trial at Children's National. He received his 2 injections (either vaccine or placebo) a couple months ago and is doing very well, but mother is concerned because he will start school soon and has very mild asthma. (She felt this was a risk factor for severe disease but plenty of studies show that this is not a risk.) She had a few great questions, but what concerned me most is that she had heard from others that some healthcare providers were planning to administer COVID-19 vaccines to children 9-11 years of age which of course is not an authorized age group. I don't know if this is true, but I do know this is one of the worst ideas I've heard, right up there with drinking bleach.

DO NOT make up your own vaccine schedules. How would you know what dose to give a 9 year old child? What if there is a severe adverse reaction? Remember also that you need to report all vaccine doses administered. If you want to get involved with giving COVID-19 vaccines to children under 12, join a clinical trial. 'Nuff said.

A 3rd Vaccine Dose, Plus a Non-COVID Item

Bud WiedermannAugust 15, 2021October 24, 2021Leave a comment

A notable week for new vaccine recommendations for immunocompromised individuals, but could be confusing for some. Also, a bit of new information about a medical mystery that's been brewing the past few months.

3rd Dose of COVID-19 Vaccine for Moderately to Severely Immunocompromised People

Both FDA and ACIP weighed in this week to recommend a 3rd dose of mRNA vaccine to a subset of immunocompromised people. (Not enough data at this time to make any judgment for those who received Janssen/Johnson&Johnson vaccine.) These individuals as a group tended not to respond with robust immunity after the standard 2-dose regimen, and now we have some new data suggesting a modest improvement after a 3rd dose. Note however that this is just a modest improvement, many individuals still may not be protected after the 3rd dose and all should continue to use masks, social distancing, and good judgment in avoiding crowds, etc., as if they were not immunized. It is tough to exactly spell out what moderate/severe immunocompromise is, but essentially all of these patients are being followed closely by whomever is prescribing their treatments and would be able to advise them on an individual basis. CDC provides excellent explanations.

Ever Seen a Case of Melioidosis?

I haven't, and I hope I don't. It's a serious infection caused by Burkholderia pseudomallei that normally is seen mostly in adults with underlying conditions residing in eastern Asia, northern Australia, and to a lesser extent in Africa, the Caribbean basin, and Central and South America. This past week the CDC reported the 4th case of melioidosis in the US this year not connected with any travel or other risk factors for the disease or to each other. These isolated cases have occurred in Texas, Kansas, Minnesota, and Georgia. Two of the 4 cases have occurred in children. Furthermore, genetic testing has shown all 4 isolates to be closely related so likely from a common source, as yet unidentified.

The clinical presentation often is nonspecific, with severe pneumonia and/or a typical septic shock presentation. Sometimes draining abscesses can develop. The organism is high risk to lab personnel and they should be warned if meliodosis is suspected. Also, many of the automated and high-tech laboratory identification machines can misidentify this organism; I suspect all the clinical labs in our area are aware of this since so many notifications have gone out, but if by chance you have a severely ill patient with a bacterial culture growing any Burkholderia species (especially B. cepacia or B. thailandensis) or Chromobacterium violaceum, Ochrobactrum anthropi, Acinetobacter spp., Aeromonas spp., and maybe even Pseudomonas spp., please check with the lab.

Something to Distract You From the Bad Variant News

Bud WiedermannJuly 25, 2021Leave a comment

Things aren't looking great around the country, much less the world, as the delta variant shows just how effective it is at spreading including among vaccinated individuals. Here's a couple pieces of news to cheer you up.

School Bus Transmission May Not Be All That Terrible When Done Correctly

An observational study published online in the Journal of School Health suggests that spread of SARS-CoV-2 on school buses isn't that high. Investigators reviewed existing data from 15 school buses in Virginia between August 24, 2020 and March 19, 2021 when they were operating at near capacity. In general there were 2 students per seat, universal masking, simple ventilation strategies, and regular pooled saliva testing of everyone with confirmation of positives by a PCR nasal swab. They found 39 students who were positive but no apparent transmission on the buses themselves.

Of course this study has limitations, including the retrospective observational design that didn't allow confirmation of a lot of details, the small sample size, and perhaps most importantly the fact that this was all before the delta variant became dominant. Still, it does offer some reassurance regarding transmission on school buses.

GBS and the Janssen Vaccine

You might expect me to file the association of Guillain-Barre syndrome and the Janssen (Johnson & Johnson) vaccine as bad news, but the fact that it is still really rare is actually a good thing. The ACIP met on July 22 to discuss the situation; you can access the key slide deck online. With 12.6 million doses of the vaccine administered through the end of June, 98 cases of GBS have been reported. The highest risk group was men 50-64 years of age at 15.6 per million vaccine doses, still far below the risks associated with infection itself.

We now know of rare side effects with the 2 mRNA vaccines (myopericarditis) and with the Janssen vaccine (TTS (thrombosis with thrombocytopenia syndrome) and GBS). Still, these side effects are so rare that the benefits of vaccination clearly outweigh risks of serious complications from COVID-19 disease. Immunization is still the best choice for everyone.

Tag: COVID-19 vaccine