FDA standards regarding “vaccine effectiveness” (VE) request that the 95% lower bound estimate is over 30% VE, so that you can be pretty sure that there’s a substantial effect. When lives are on the line, it’s important to be pretty sure of things.
Regarding what is to be taken as the primary endpoint, one of the best options would be to choose hospitalization. Again, this is to be sure that the estimated protection is substantial. Even though hospitalization is a better primary endpoint, the FDA still went ahead and suggested the lower standard of simply a symptomatic infection:
A great question to ask of booster shots are: Do they meet FDA standards?
Not for young children:
Young Kids
With the better standard of hospitalization, booster shots also fail to earn the moniker “effective” …
Immunocompetent Adults
For adults not immunocompromised, monovalent boosters fail the standard, and bivalent boosters begin to fail as early as Day 60 after the shot for non-elderly (Day 120 for elderly).
But do the booster shots protect the vulnerable who are most at risk?
Immunocompromised Adults
For those most at risk, booster shots fail all around.
Evidence suggests that booster shots should be taken off of the market for failing to meet “effectiveness” standards, with the added factor of the original Phase 3 trials leading to more than 1 serious adverse event (AE) per 1,000 injectees.
That rate of serious AEs is 130 times the VAERS reporting rate for typical vaccines.
Reference
[CDC presentation on booster shot VE] — COVID-19 vaccine effectiveness updates. 19 April 2023. Ruth Link-Gelles, PhD, MPH. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/05-COVID-Link-Gelles-508.pdf
[1 serious AE per 800 injectees = 1,250 per million; 130 times higher than VAERS reporting rate for typical vaccines] — Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Sep 22;40(40):5798-5805. doi: 10.1016/j.vaccine.2022.08.036. Epub 2022 Aug 31. PMID: 36055877; PMCID: PMC9428332. https://pubmed.ncbi.nlm.nih.gov/36055877/
[typical serious AE reporting rate is 9.6 serious AE reports per million net doses distributed] — CDC. Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, 1991--2001. https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm
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