Thread by @mahesh_shenai

fda.gov/media/153507/d…
1/ Interesting risk-benefit analysis for 5-11yos from Dr.Yang, an FDA epidemiologist, providing scenarios at VRBPAC (not Pfizer sponsored analysis). It favors the OPTION for vaccine, but argues against any MANDATE. This🧵interprets this presentation.

2/ Analysis calculates the number of Cases, Hospitalizations, ICU stays, and Deaths prevented by vax, compared to the excess of same complications by myocarditis/pericarditis. Myo/pericarditis is the only complication considered.

3/ They tested several scenarios with peak incidences (recent Delta phase), vs. baseline incidences. They also tested for assumptions on various VE and rates of vax-induced myocarditis, broken down by M/F.

4/ In at least one scenario for males (Scenario 3- incidence 5-10% of “peak”, the rates of hospitalizations, ICU stays and deaths by vax-induced myocarditis/pericarditis ALONE exceeds that prevented by COVID 19, for both genders. THIS IS A CRITICAL FINDING.

5/ Other scenarios (peak, base cases) are more favorable to the vaccine, particularly for case reduction – but as you consider more serious outcomes (hospitalization, ICU, death) it approaches parity.

6/ The true scenario is somewhere in between, but closer to Scenario 3. Because the “base case” was taken during the recent Delta phase, its not really the “base case”, but only slightly off peak. Scenario 3 probably better represents the base case.

7/ fda.gov/media/153514/d… These scenarios also assume that vax-induced myocarditis has ZERO mortality. However, an earlier CDC presentation during VRBPAC states “classic” myocarditis may have a 4-7% mortality. How sure are we that vax myo is not similar to "classic" myo?

8/These scenarios analysis ALSO DO NOT take into account serious adverse events OTHER than myocarditis. It also does not take into account moderate/severe adverse effects, which occur in the 0.1--2% range (1,000-20,000/1Million). (Taken from Frenck Jr, NEJM)

9/ These scenarios also do not look at other specific subgroups – like the COVID-recovered, who will have even LOWER INCIDENCES, LOWER VE, and the SAME (if not higher adverse event rate). For the COVID-recovered, the risk may outweigh the benefit. See my substack on this...

9b/ COVID-RECOVERED Children 5-11 - The MOST NEGLECTED SUBGROUP. maheshshenai.substack.com/p/the-most-neg…

10/ These scenarios are FDA analysis. One can conclude that vaccination will save “cases” beyond risk, but PREVENTION OF SEVERE C19 DOES NOT CLEARLY OUTWEIGH SEVERE VAX MYOCARDITIS alone, and not even considering OTHER SEVERE AEs.

11/ If vaccinations are to be MANDATED, then the benefit must OVERWHELMINGLY outweigh the risks for ALL SCENARIOS, in ALL SUBGROUPS. This analysis shows that certain SUBGROUPS in some SCENARIOS may be HARMED.

12/ These are NOT SMALL subgroups. Males make up 50% of the population, and the COVID-recovered may be 1.8 M, at least. There are intersections, too. What about COVID-recovered 5-11 yo males?

13/ Based on this, MANDATING vaccination in 5-11 yos simply transfers the risk from one SUBGROUP to another. There is no moral justification for this.

14/The FDA and CDC should be weary that their blanket approval (without flexibility) will be misconstrue by private and public orgs as a license to MANDATE, potentially putting certain children (males, recovered) in harms way.

15/ Sensible approach is allow 5-11 yo vax as a parental OPTION, and recommend EQUIPOISE. May make sense in high-risk children (eg w/comorbidities), but advise caution in certain SUBGROUPS like males, and COVID-recovered. @FDA @CDCgov needs to provide appropriate qualification.

16/ Thank you.