Monitoring of adverse events after COVID-19 mRNA vaccination
Jama. published online September 3, 2021. doi: 10.1001 / jama.2021.15072
Commentary.
This study was conducted to monitor 23 serious outcomes weekly using comprehensive health records from diverse populations.
Representing an interim analysis of safety surveillance data from the Vaccine Safety Datalink, 10,162,227 vaccine-eligible members of eight participating US health plans were monitored with weekly updated administrative data, a situation supplemented by medical record reviews of selected outcomes from December 14, 2020 to June 26, 2021.
Monitored outcomes included the incidence of serious outcomes such as acute myocardial infarction, Bell's palsy, cerebral venous sinus thrombosis, Guillain-Barre syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome.
The incidence of events occurring among vaccinees 1-21 days after either dose 1 or 2 of the messenger RNA (mRNA) vaccine, at the same calendar date as the most recent dose 22-42 days earlier, rate ratios (RRs) were estimated by Poisson regression and adjusted for age, sex, race, ethnicity, health insurance, and calendar date.
As a result, a total of 11,845,128 doses of mRNA vaccine (57% BNT162b2; 6 175813 first dose and 5669 315 second dose) were administered to 6.2 million people (mean age 49 years; 54% women), which were analyzed.
The risk of ischemic stroke versus the incidence of events per 1,000,000 person-years during the comparison interval was 1612 versus 1781 (RR, 0.97; 95% CI, 0.87-1.08).
For appendicitis, 1179 vs. 1345 (RR, 0.82; 95% CI, 0.73-0.93)
For acute myocardial infarction, 935 vs. 1030 (RR, 1.02; 95% CI, 0.89-1.18)
The vaccine/outcome association did not meet the pre-specified requirements for signal, with confirmed anaphylaxis rates of 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273 (95% CI, 3.3-7.6) per million doses of mRNA-1273.
Based on these analyses, the incidence of selected serious outcomes is not significantly higher at 1-21 days post-vaccination compared to 22-42 days post-vaccination according to the interim analysis of mRNACOVID-19 vaccine surveillance.
