Thread by @mahesh_shenai

1/ As the @FDA decides on EUA for 5-11 yos, w/ minimal efficacy data, the most NEGLECTED subgroup are COVID-recovered 5-11yos, who have virtually no representation in any study. This THREAD attempts to quantify the benefit of vaccination in this subgroup. @noorchashm @ToddZywicki

2/ Recovered 5-11 yos have 3 coinciding reasons for minimal benefit from vax: 1) extremely low rates of symptom. morbidity, 2) adult data suggesting notable protection (70-90%) from NI alone, 3) adult data suggesting vax in recovered is 18-33%. Let us examine each: @JeanRees10

3a/ 1st, from CDC data below – 5-11yos (exclusively unvaxed) currently one of the highest inc, of infxn (currently near peak at 218/100k-wk). Deaths are virtually immeasurable. This is near the peak of the most recent wave. On average throughout pandemic , it is much lower.

3a/ First, from CDC data – 5-11yos (exclusively unvaxxed) currently one of the highest incidences of infection (currently near peak at 218/100k-wk). Deaths are virtually immeasurable. This is near the peak of the most recent wave. On average throughout pandemic , it is much lower

3b/ However, hospitalizations are also very low. Below is a CDC graph of incidence in 5-11 yos, during most recent spike. Even though this group is unvaxed, the hospitalization rate is the lowest of any age group by 0.25-0.5x.

3c/ These stats are for ALL 5-11yo individuals, not recovered children. The next part will use adult data demonstrating at least some degree of natural protection conferred.

4a/ nejm.org/doi/full/10.10… The pivotal Pfizer trial, at 6 months demonstrated a 72.6% level of protection from NI. Other studies, have shown 70-95% protection as in this metanalysis medrxiv.org/content/10.110…

4b/ If we annualize the weekly incidence, hospitalization, mortality rates from above (175, 0.5, 0.01)/100k-week, the annual incidences are 9100,26,0.52/100k. 175/100k-year is the average estimate from last peak. Average is lower. See table below.

@FDA @noorchashm @ToddZywicki 4c) If we apply a 75% risk reduction to these rates of incidence, hospitalization, and mortality in 5-11yos, we can expect much lower rates of incidence in the recovered child: (2275,6.5,0.13)/100k-year. This is before a putative vaccination.

5a) Let us then look at the result if vax given in this group. In recovered adults, the VE for Pfzr was 19.2%. Let us give benefit of the doubt, & assume VE is as high as 50% after 6 months. This would lead to a post-vax inc are (1138,3.3, 0.07)/100k-yr.

@FDA @noorchashm @ToddZywicki 5b) The absolute differences for infxn, hosp, death are the same (1138,3.3,0.07)/100k-year. From there we can calculate a number needed to treat (NNT), or the number needed to vax in order to prevent 1 case of infxn, hosp, or death.

5c) The NNTs for infection, hosp, death are 88, 31k, and 1.5M per year. You would need to vax 31k and 1.5M recovered children in order to save one hospitalization or death per yr, respectively in that group. Need to vax 88 to save one infection, likely mild or asymptomatic.

5d) For comparison, if one assumes a 90% VE in 5-11yo COVID-naïve kids, the NNTs are 12, 4.2k, and 214k. In this scenario, recovered 5-11yos get 1/7th of the benefit of vax compared to naïve counterparts.

5e) One can play around with these numbers, lower the immunity protection, increase the VE. But in virtually no realistic circumstance does VE in the recovered provide anywhere near the benefit to a naïve counterpart of the same or any other age group.

6a) So extrapolating adult NI protection and VEs into baseline 5-11yo incidences, the cascading effects make the level of ABSOLUTE protection relatively small. Every parent of a recovered child should ask what are the ABSOLUTE risks of the vax?

https://twitter.com/madlibtweets/status/1441236310790918145

6b) See this great thread by @madlibtweets 4 that disc. Pnt is, the margin of safety vs. benefit is the NARROWEST for the recov 5-11yos, and should be considered in any MANDATE. Also, this grp has the longest horizon for long-term, currently unknown AEs

6c) Also consider many safety trials have excluded young AND COVID recovered. The risk of the unknown its real. Just b/c evidence is absent, this is not evidence of absence.

7) For the record, I believe it reasonable for parents to have the OPTION to vax their children, if they believe it is in their best benefit. It should also be reasonable for parents of adolesecents (and particularly the recovered), to make that decision without a mandate.

8) Thank you for reading. I respect objectivism, and will listen to any critiques/corrections/counterpoints to those made above. I need to speak up because this seems to be the MOST NEGLECTED subgroup, but needs our greatest protection.