scientific evidence & data for deciding whether 5-11 year-olds need a booster

[truepeace1982]

It's good that the FDA has approved boosters for 5-11yos since some (eg immune compromised) may need them, but that doesn't mean they should be recommended (or mandated) for all in this age group.

First, I love vaccines. They are one of the biggest medical & public health advances ever, right up there with plumbing & antibiotics. My wife & I have gotten our kids all their childhood vaccines and we're all fully vaccinated for Covid. I mention this just so you understand that I come down firmly on the pro-vaccine side of pre-pandemic vaccine debates.

Two doses of mRNA Covid vaccine are already extremely effective, especially in the young who have competent immune systems. Data show memory B cell immunity does not wane after 6mo [1] and T cells also remain effective [2, 3], even if neutralizing antibodies (nAbs) do wane. Boosters raise nAbs for a few months but then they drop again.

Also, absolute risk to this age group is low to begin with even without any vaccination, so 2 doses reduces that risk to even tinier levels. What is the number needed to treat (NNT) for dose 3 in 5-11yo age group to prevent 1 hospitalization? To prevent 1 death? No one has produced these numbers yet that I've seen, but NNT is an important stat to know before widespread public health recommendations.

Kids 5-11 had such a low risk of death even unvaccinated that the FDA's own data [4] showed about 1 million kids needed to get vaccinated to prevent 1 death. This was around the time when this age group's doses were first FDA approved. Data around that time from UK's JCVI for the 12-15 age group split out numbers by kids getting 1 vs 2 doses and showed that given 1 dose, NNT to prevent 1 ICU for 2nd dose given 1st prior was more than 6 million [5]. NNT for dose 3 given 2 prior should be much, much higher given the lasting memory B & T cell competence.

NNTs in the millions are pretty high. For context: Many adults refuse statins when the efficacy is presented to them in NNT form. NNT to prevent 1 death in the next year from daily statin use is around 100. Also for an opinion from a highly trained expert: Bob Wachter, chair of the department of medicine at UCSF & frequent Covid Twitter commenter, said publicly in Jan that NNT of ~1100 was very high, too high for him to want to get a 2nd booster [6].

It's also worth noting that a large fraction of kids in this age group have already been infected with Covid, 77% of 5-11yos according to this antibody survey with roughly half of those having happened since Nov/Dec timeframe [7], and this is significant because studies show infection after full vaccination provides better immune protection than a booster [8]. So it's clear that not everyone in this age group needs a booster even if only due to these prior infections.

Boosters were overly pushed on teens [9] and college-age young adults [10] with some public health bodies overruling their own scientific expert panels and some prominent experts resigning in protect [9, 12]. I'm worried something similar will happen in the 5-11 age group.

Unlike what happened with teens & college age, both NNT & long-term efficacy should be addressed by the CDC, the Amercian Academy of Pediatrics (AAP), local DPHs, or schools before any recommendations (or mandates) for widespread boosting in the 5-11 age group.

New England Journal of Medicine just published a good editorial by Paul Offit, who is an internationally recognized vaccine expert, member of the FDA's vaccine advisory committee, and notably the most prominent & vocal pro-vaccine voice of the past several decades (he's sort of the opposite of Robert Kennedy). It does a great job concisely explaining how we got to where we are and putting things in good historical perspective. Well worth a read. (But if you prefer to listen to him, the 7min section of this interview with him starting where the link picks up is also good. [12])

[1] https://pubmed.ncbi.nlm.nih.gov/35134333/

[2] https://www.nature.com/articles/s41564-022-01123-x

[3] https://www.biorxiv.org/content/10.1101/2021.12.06.471446v1

[4] https://www.fda.gov/media/153507/download

[5] https://www.gov.uk/government/publi...children-aged-12-to-15-years-3-september-2021

[6] https://twitter.com/KarlPfleger/status/1487517613588549633

[7] https://www.nature.com/articles/d41586-022-01231-y

[8] https://finance.yahoo.com/news/getting-sick-omicron-protects-against-183659818.html

[9] https://www.wsj.com/articles/danger...-omicron-vaxx-requirement-mandate-11640107759

[10] https://bariweiss.substack.com/p/universities-covid-policies-defy?s=r

[11] https://www.nejm.org/doi/full/10.1056/NEJMe2203329

[12] https://www.youtube.com/watch?v=wkz1ln5AJ5Q&t=79s

I flair'ed evidence based input only, but I welcome honest questions & the like, editorials from reasonably credentialed people, etc. I just don't want "my pediatrician said to get it and I'm not going to questions them even though they didn't give any reasons" or anecdotes. I especially welcome any published studies or preprints or other data anyone thinks is on-point for deciding whether to give a booster in this age group.

[Edited to correct typo: "For I love vaccines" -> "First, I love vaccines."]

 

[dan87]

@truepeace1982 “Boosters were overly pushed on teens and college age adults” and OP you proceed to cite a WSJ opinion column, a controversial and partially discredited opinion columnist in Bari Weiss, and a random YouTube interview. This isn’t science based at all.

You also focus entirely on preventing death in your earlier claim, which I think we can all agree is not the basis behind a recommendation of a booster. The FDA makes clear in their own authorization that’s not why they’re recommending it:

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D.”

https://www.fda.gov/news-events/pre...pfizer-biontech-covid-19-vaccine-booster-dose

Edit: for citation #6 did you really just link to your own tweets?

 

[truepeace1982]

@dan87 Both my refs [9] & [10] are authored by Marty Makary, MD, MPH, professor at the Johns Hopkins School of Medicine. He's well credentialed in both clinical medicine and public health policy, which is one of his research areas. The fact that one of the pieces appeared in the WSJ and one was hosted on some particular person's substack are irrelevant. Bari Weiss was not the author.

The YouTube interview is with Paul Offitt. Few to no people are more authoritative and well respected voices on vaccines than him and few have historically been more pro-vaccine than him. He is authoritative and his comments in the 7min interview segment I specifically linked to provide useful insights into how the existing CDC booster recommendations came about. This segment in fact specifically explains how unscientific recommendations can become national public health policy. The fact that it was an YouTube is not the part to focus on. Focus on the authority of the speaker.

The question of whether preventing death is the goal of boosters vs preventing infection is precisely the subject of Paul Offit's NEJM editorial that is my reference [11]. The public should be told what the goal is and if justification for boosters is infection prevention, authorities (& pediatricians) should explain to the public (& their patients' parents) that this is unprecedented in the history of vaccines.

Re [6]: Mostly I was citing UCSF medicine chair Bob Wachter's Tweet, but I linked my own ReTweet quote of his Tweet just so I didn't have to explain the context as much directly in the Reddit post. Readers can easily make the 1 extra click to read his Tweet directly.

 

[truepeace1982]

@dan87

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D.”

Okay, so what is the Number Needed to Treat with dose 3 given a population of 5-11yos who already have 2 doses to prevent 1 hospitalization (a) in the first 4-6mo after that 3rd dose, and (b) for the period of time after 4-6 months from dose 3? For (b) does the booster provide any benefit in this age group after 4-6mo? This latter is an important question for any parents who may be worried that the safety of giving 2-3 doses per year ongoing may not be the same as the safety of just 2 or 3 doses and then stop.

The 2nd part of the quote addresses long Covid. Thanks for bringing that up as that is many parents' main justification for wanting to prevent infection (or reduce its chance) as much as possible by any means necessary. But there are several responses to this:

(1) The Califf quote above just says "may experience". That's pretty vague statistically. Is there data showing the risk to this age group of long Covid is significant? Or that boosters in any way decrease the long-term risk of long Covid? Intuitively it makes little sense that boosters would help if (as I showed with my original citations) 2 doses provide lasting memory B cell & T cell immune response. The reason boosters help prevent short-term mild symptomatic infection is because the high levels of circulating neutralizing antibodies (nAbs) rise temporarily after boosting and kill the virus more quickly than the memory B & T cell response can. But if that B & T cell response is robust it kicks in shortly after infection. Thus, boosters' main benefit is the fast action of the nAbs. It would be strange for the fast action to be the mediator of increased protection of a long-term effect.

I remember seeing evidence that full vaccination reduces the risk of long Covid and haven't seen either a study nor any people suggesting that boosters further reduce the risk. Do you know of one?

So far the science I've seen suggests that kids' long Covid risk is overblown. See for example, this Stat News story which discusses these 4 published studies, 2 of which have been published in 2022, plus 1 study of adults also from 2022. (And note the 1st author of that Stat News story is an infectious disease physician and an assistant professor of medicine and of neurology at the Yale School of Medicine who is studying how Covid-19 affects the brain.)

The sense I get from this stuff without diving in deeply enough to try to become an expert is that good data on long Covid has been hard to come by and these new-ish studies don't prove perfectly that long covid in kids should not be a worry, but the burden of proof is now on finding any good data showing that there is a reason to worry. The benefit of boosters in this age group seems very small. The risk of long Covid seems small too. It seems a stretch and certainly one not yet justified by any hard data to suggest that boosters would reduce absolute long Covid risk meaningfully. But I welcome pointers to any data showing that they do.

 

[conservativepatriot]

@truepeace1982 Thank you for a nuanced and evidence based post! I'm vaccinated and boosted 36 weeks pregnant. It's nice to see a convo that isn't just "pro" or "anti".

 

[truepeace1982]

Update: The CDC has recommended boosters for all 5-11 year olds.

Newsweek opinion piece from Marty Makary (prof at John Hopkins and public health expert) on their process: https://www.newsweek.com/why-america-doesnt-trust-cdc-opinion-1713145

Justification for the recommendation was a 140 child Pfizer study that showed raised antibody levels, an effect everyone knows is temporary. Pfizer said there was no demonstration of efficacy against Covid (so no quantification of the amount of benefit kids get from 3rd dose vs just having 2 doses). Exactly the opposite of what I suggested in my post should be required before a recommendation (or mandate) is issued.

Quotes:

" "if we say should more people will get boosted versus may, then we may have more data that helps us really define where we're going." Dr. Brooks was essentially suggesting that boosting in this age group would be a clinical trial conducted without informed consent."

[...]

"Most remarkably, it didn't seem to matter to the CDC that 75.2 percent of children under age 11 already have natural immunity, according to a CDC study that concluded in February. Natural immunity is certainly much more prevalent today, given the ubiquity of the Omicron variant since February. CDC data from New York and California demonstrated that natural immunity was 2.8 times more effective in preventing hospitalization and 3.3 to 4.7 times more effective in preventing COVID infection compared to vaccination during the Delta wave. These findings are consistent with dozens of other clinical studies. Yet natural immunity has consistently and inexplicably been dismissed by the medical establishment."

 

[ruths]

@truepeace1982 Thanks so much for sharing your thought process and approach, and so well-referenced. The way you've walked through your analysis is helpful to me as a toddler parent for determining risk/reward calculations in regards to their vaccine wait as well.