Monitoring of adverse events after COVID-19 mRNA vaccination
doi: 10.1001 / jama.2021.15072
Commentary
Because of its importance in ensuring the safety of vaccines against COVID-19, maintaining confidence, and informing policy, this study used comprehensive health records from diverse populations and was designed to monitor 23 serious outcomes each week.
The study represents an interim analysis of safety surveillance data from the Vaccine Safety Datalink, supplemented by a medical record review of outcomes from December 14, 2020 to June 26, 2021.
BNT162b2, mRNA-1273COVID-19 vaccine at a risk interval of 21 days in individuals was compared with an interval of 22 to 42 days in individuals after vaccination, dose 1 or 2 after dose 1 or 2 was compared.
The main outcomes and measures analyzed 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 to 21 days after either dose 1 or 2 of the messenger RNA (mRNA) vaccine, with the most recent dose 22 to 42 days on the same calendar day, 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 11845 128 doses of mRNA vaccine were administered to 6.2 million people, and the rate of events per 1,000,000 person-years during the risk versus comparison interval for ischemic stroke was 1,612 versus 1,781. The rates for appendicitis were 1,179 versus 1,345 and for acute myocardial infarction, 935 versus 1,030.
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. 6).
An interim analysis of the mRNACOVID-19 vaccine surveillance showed that the incidence of selected serious outcomes was not significantly higher at 1-21 days post-vaccination compared to 22-42 days post-vaccination.
