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

Publication date: Jul 15, 2023

Background: The large-scale use of mRNA COVID-19 vaccines during the pandemic was associated with enhanced safety monitoring to ensure accurate and timely review of safety. We reviewed the mRNA-1273 (original strain) safety profile following 2 years of use (>772 million administered doses), primarily focusing upon predefined safety topics (ie, adverse events of special interest [AESI]) proposed in advance of COVID-19 vaccine use. Methods: Cumulative mRNA-1273 safety data from spontaneous adverse event (AE) cases reported to the Moderna, Inc., global safety database (GSDB) between December 18, 2020, and December 17, 2022, were included. Reporting rates of AESI were calculated per 1 million doses of mRNA-1273 administered. Observed-to-expected (OE) ratios were computed by comparing observed rates of AESI to the background/expected rate for these events to evaluate potential associations with mRNA-1273. Results: There were 658,767 identified case reports, associated with 2,517,669 AEs. Most AEs were non-serious (83.4%); 0.7% were fatal. AESI represented 13.7% of all AEs, with reporting rates for most AESI below the expected background incidence. Exceptions included anaphylaxis (OE ratio 3 days after vaccination, 2.19 [95% CI, 2.02-2.37]), myocarditis (OE ratio 7 days after vaccination, 1.41 [1.32-1.51]; among men aged 12-40 years, 9.75 [7.74-12.3]; and individuals aged 12-40 years, 3.51 [3.19-3.86]), and pericarditis (OE ratio 7 days after vaccination in individuals aged 12-40 years, 2.54 [2.16-2.99]). Conclusions: With the exceptions of anaphylaxis, myocarditis, and pericarditis, this safety analysis of mRNA-1273 did not find evidence to suggest an increased risk for AESI identified for enhanced monitoring ahead of COVID-19 vaccine use.


Concepts Keywords
Germany Administered
Healthcare Aesi
Jeopardizing Covid
Phd23 Doses


Type Source Name
disease MESH COVID-19
disease VO COVID-19 vaccine
disease VO adverse event
disease MESH anaphylaxis
disease VO vaccination
disease MESH myocarditis
disease MESH pericarditis
drug DRUGBANK Methylphenidate
disease VO USA
drug DRUGBANK Coenzyme M
disease VO vaccine
disease VO Comirnaty
disease VO effective
disease MESH infection
disease VO vaccine effectiveness
disease VO population
disease VO effectiveness
disease MESH Emergency
disease MESH sequelae
disease MESH allergic reactions
disease MESH inflammation
disease VO time
disease VO immunization
disease MESH thrombosis
disease MESH thrombocytopenia
disease MESH syndrome
drug DRUGBANK Methionine
disease IDO process
disease MESH death
disease IDO intervention
disease VO vaccination dose
disease VO frequency
disease IDO quality
disease MESH causality
disease VO vaccine dose
disease VO age

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