Global Safety Assessment of Adverse Events of Special Interest Following 2 Years of Use and 772 Million Administered Doses of mRNA-1273

"Methods

Data Sources

The Moderna GSDB [Moderna global safety database] collects safety data from spontaneous reports that are submitted by regulatory authorities, health care providers, and consumers where mRNA-1273 is authorized for use...

From 18 December 2020 (first international emergency use authorization issuance) to 17 December 2022, the GSDB was reviewed for valid case reports: those with an identifiable reporter, patient, adverse reaction, and suspected product. 

Discussion

... Pharmacovigilance efforts made during the COVID-19 pandemic have utilized background rates for conditions anticipated to be AEs, allowing for a more intuitive approach to characterizing strength of association and one more readily suited for additional analyses (eg, estimating strength of association categorized by age and sex)...  In this analysis, OE [observed-to-expected] ratios for most AESIs [adverse events of special interest] evaluated did not exceed the threshold of the lower bound of the 95% CI >1 for the standard risk window of 21 days following vaccination. Reports of certain AESIs occurred at a relatively low rate, with 2588 cases of anaphylaxis, 6702 of myocarditis and/or pericarditis, 230 of TTS, and 683 of GBS. However, as previously reported, AESIs of myocarditis with or without pericarditis and pericarditis demonstrated elevated reporting rates in subgroup analyses, with more marked associations observed in sensitivity analyses that restricted timing to a 7-day risk window after vaccination. Rates of anaphylaxis were also increased during the 3 days after vaccination. Our analysis confirmed an elevated risk for anaphylaxis, myocarditis, and/or pericarditis but not for TTS or GBS. Upon confirmation of these risks, anaphylaxis, myocarditis, and pericarditis were added to mRNA-1273 prescribing information."