R to @KrugAlli: We are grateful to Restore Childhood for its funding allowing open-access publication of our work. Please consider supporting Restore Childhood whose mission is “ to ensure parents have the information, community, and courage to stand up for their children” (http://restorechildhood.com/donate).
9/9
R to @KrugAlli: Implications: To build trust & reduce hesitancy, public-health agencies should use benefit-risk models that can support stratification of vaccine recommendations not only by age & sex but also by prior-infection & comorbidity status. Blanket recommendations can do harm.
6/9
R to @KrugAlli: The FDA's benefit-risk assessments should be more rigorous, and, in particular, the FDA should expect the CDC to provide the information necessary to ensure rigor.
(For both its Pfizer and Moderna assessments, the FDA failed to obtain data from the CDC on incidental COVID hospitalizations.
For both assessments, the FDA claims that age/sex specific VAM/P information from the CDC’s VSD system is not available; e.g., for its Pfizer assessment the FDA author team stated, “[W]e have no access to VSD data for smaller age/sex subgroups [e.g., 16–17-year-old males].”
Finally, for its mRNA-1273 assessment, the FDA failed to request that the CDC disaggregate COVID hospitalization data for the age range 18–45 into data for the subranges 18–25, 26–35, and 35–45.)
7/9
R to @KrugAlli: Results: For 18-25 males, our modeling suggests vaccine risks (VAM/P hosps) outweighed benefits (COVID hosps prevented) in more likely scenarios—creating 8% to 52% more VAM/P hosps than prevented. Findings were validated by later data from Ontario and Connecticut. (Details covered in extensive supplements.)
4/9
R to @KrugAlli: We also illustrate how our model can be modified to incorporate a comorbidity (obesity) as a risk modifier by providing a benefit-risk assessment of mRNA-1273 vaccination of 18– 25-year-old males based on their Body Mass Index (BMI).
We find that for BMI levels 23–34 (from the ideal to the moderately obese), prior-infection status determines whether vaccination is beneficial, but for the those with high BMI (35–44) in high-infection-risk scenarios vaccination becomes beneficial even for those with prior-infection protection.
5/9
R to @KrugAlli: The FDA approved mRNA-1273 on 31 Jan 2022 (for those of ages 18 and up) based on its assessment that vaccine benefits “clearly” outweighed risks even for young males at high vaccine-attributable myocarditis/pericarditis (VAM/P) risk. However, the FDA benefit-risk analysis had significant shortcomings such as omitting benefits conferred by prior COVID infection.
2/9
R to @KrugAlli: We built a model extending the FDA's by accounting for prior-infection protection, incidental COVID hospitalizations, finer age-stratification of hosp rates, and more accurate VAM/P-rate estimates. We used data available to the FDA at the time of its mRNA-1273 analysis (3rd week of Jan 2022). We assumed a 5-month eval period as the FDA did.
3/9
Pinned: Our new paper in @Vaccines_MDPI reanalyzes the FDA's benefit-risk assessment of Moderna's mRNA-1273 COVID vaccine (orig formulation). We focus on hospitalizations—those prevented by vaccination vs. those caused by vaccine-attibutable myocarditis/pericarditis (VAM/P). We incorporate benefits from prior COVID infection—something the FDA overlooked. Our analysis is restricted to males 18-25 (those at highest VAM/P risk).
Bourdon PS, Duriseti R, Gromoll HC, Dalton DK, Bardosh K, Krug AE. A Reanalysis of the FDA’s Benefit–Risk Assessment of Moderna’s mRNA-1273 COVID Vaccine Based on a Model Incorporating Benefits Derived from Prior COVID Infection. Vaccines. 2026; 14(2):165. https://doi.org/10.3390/vaccines14020165
cc @KevinBardosh
1/9
41-year-old bobsledder Elana Meyers Taylor just became the oldest Olympic gold medalist in history.
But her greatest title isn’t “Olympian.”
It’s being a mother of two precious deaf children — one with Down syndrome — and being openly Christian, placing God above every medal.
“God put me here for a specific reason, and I don’t think it’s just to win medals. At the end of the day, I’m in this sport to glorify God, so if that means I come in last place, or I win the gold medal, that’s what I’m going to do.”
@anish_koka has been terrific explaining FACTS on the Moderna -FDAPrasad story
Anyone who slings personal insults rather than acknowledge the facts is not acting in good faith
it’s that simple
Generational disaster with grave decades-long consequences!
I don’t know @JenniferSey but she has been one of too few who had the moral clarity and the courage speak up, for our children and young.
We need more like her!
This is the strongly worded advice from the New Zealand government’s group of vaccine experts in relation to the under 18s. It wasn’t implemented.