mRNA covid-19 vaccine trials

Fraiman, Erviti et al.

Serious adverse events of special interest following mRNA covid-19 vaccination in randomized trials in adults

Vaccine, Vol 40, Issue 40, 22 September 2022, pp. 5798-5805

Science Direct

DOI: https://doi.org/10.1016/j.vaccine.2022.08.036

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Pfizer (NCT04368728) DOI: https://doi/10.1056/NEJMoa2034577

Moderna (NCT04470427) DOI: https://doi/10.1056/NEJMoa2035389

Pfizer and Moderna used nearly identical definitions, consistent with regulatory expectations. An SAE was defined as an adverse event that results in any of the following conditions: death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment.”