| It's an interesting publication, and a necessary one. However, there are a couple of thoughts to keep in mind: 1. The confidence intervals for the risk differences are wide, and some categories include negative numbers. This means that perhaps the vaccines were protective (?) against these other outcomes, but overall the trend based on this analysis is the vaccines were associated with increased risk of these other bad outcomes. 2. Capturing and reporting SAEs in the study designs are sensitive but not specific (i.e. they try to capture everything and aren't particularly concerned with verifying the cause of the SAE). For example, in the Pfizer study, they captured data related to any SAE from the start of consent to 6 months after the last dose of trial vaccine [1]. That is a long time for typical medical problems to crop up. I would like to know a comparison between the intervention group and the estimated rates of such illnesses for an age-matched population. 3. In this study they looked at all SAEs as compared to any SAE (which is what the FDA did). I don't want to discredit they study in any way and it is a valid analysis. However, it is important to keep in mind that when someone becomes ill, injury to one organ system can cause downstream injury to a second (for example a heart attack reduces cardiac output, which causes kidney injury). One way to explain the findings here is that the vaccine triggered more secondary, unintended, bad outcomes. Another way to explain the data is that a small number of people became very ill in the peri-vaccination period and had a lot of bad stuff happen. Also keep in mind from point 2 that the time period for collecting SAEs was from consent to 6 months after the last dose of vaccine. The data presented here is interesting, and it's possible that the vaccines could be more harmful than initially thought. Overall, I am skeptical. The numbers here are still very low compared to the total number of people in the trial. If patient level data is released and there is more meat to the findings here it might change how I think about vaccination, but at this point I wouldn't change. [1] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_f... |