Full paper pdf here: Fraiman_Excess risk of serious C19 vax SAES vs C19 vax prevented hospitalizations
Fraiman, J. Erviti, M. Jones et al., Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults, Vaccine, https://doi.org/10.1016/j.vaccine.2022.08.036
Authors introductory rationale for focus on The Brighton Collaboration-defined Adverse Events of Special Interest (AESI):
The list of “adverse events of special interest (is) based on the specific vaccine platform, adverse events associated with prior vaccines in general, theoretical associations based on animal models, and COVID-19 specific immunopathogenesis. The Brighton Collaboration is a global authority on the topic of vaccine safety and in May 2020, the World Health Organization’s Global Advisory Committee on Vaccine Safety endorsed and recommended the reporting of AESIs based on this priority list. To our knowledge, however, the list has not been applied to serious adverse events in randomized trial data.”
Results of Risk-Harm Analysis:
“In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants). In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants).”
Caveats, & Attempted Sensitivity Calculation Adjustment for Bias:
“without individual participant data, we could only compare the number of individuals hospitalized for COVID-19 against the number of serious (Adverse Events of Special Interest) AESI events, not the number of participants experiencing any serious AESI. Some individuals experienced multiple SAEs whereas hospitalized COVID-19 participants were likely only hospitalized once, biasing the analysis towards exhibiting net harm. To gauge the extent of this bias, we considered that there were 20 % (Pfizer) and 34 % (Moderna) more SAEs than participants experiencing any SAE. As a rough sensitivity calculation, if we divide the Pfizer excess serious AESI risk of 10.1 by 1.20 it becomes 8.4 compared to a COVID-19 hospitalization risk reduction of 2.3; if we divide the Moderna excess serious AESI risk of 15.1 by 1.34 it becomes 11.3 compared to a COVID-19 hospitalization risk reduction of 6.4.
Going Forward , Need Individual Patient Trial Data:
“Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, as we approach 2 years after release of COVID-19 vaccines, participant level data remain inaccessible.”
