Key result
The mRNA-1273 vaccine was well-tolerated in a real-world setting, with 98% of respondents reporting local and systemic adverse events on day 1 after the second dose.
Why the study?
Although the safety of the mRNA-1273 COVID-19 vaccine had been investigated worldwide, real-world safety data were scarce in Japan.
What is the real-world safety profile of the mRNA-1273 SARS-CoV-2 vaccine in a Japanese workplace vaccination setting?
Observational (n=301)
No
What is the real-world safety profile of the mRNA-1273 SARS-CoV-2 vaccine in a Japanese workplace vaccination setting?
The mRNA-1273 vaccine demonstrated a real-world safety profile in a Japanese cohort consistent with clinical trials, with high but tolerable rates of transient local and systemic adverse events.
Answers are grounded in this paper and cite their sources.
Real-world tolerability data support short-term mRNA-1273 safety in Japanese workers; leaves open generalizability and long-term outcomes.
The mRNA-1273 Moderna COVID-19 vaccine was introduced to combat the COVID-19 global pandemic in 2020. Although the safety of the vaccine has been investigated worldwide, real-world safety data is scarce in Japan. An online, real-time survey of adverse events following immunization (AEFIs) with mRNA-1273 was conducted in the setting of a workplace vaccination program at the School of Pharmacy, Keio University from 26 June 2021, to 11 June 2022. Participants were requested to take four surveys during a seven-day follow-up period after each of the first, second, and third booster doses. The maximum number of responses, from 301 respondents, was obtained on day 0 (vaccination date) for the first dose. 98% of respondents reported local and systemic AEFIs for the second dose on day 1. No noticeable difference in local reactions was seen among the three doses. Females reported more AEFIs than males, and the young group (18-29 years) reported a higher rate than the middle age group (≥30 years) after the first dose. Age and gender differences in rates decreased at the second and third doses. This survey confirmed that the safety profile of mRNA-1273 in a real-world setting was similar to that derived from the clinical trials, and that the agent was well-tolerated.
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Okumura et al. (2022) conducted an observational in COVID-19 vaccination (n=301). mRNA-1273 SARS-CoV-2 Vaccine was evaluated on Adverse events following immunization (AEFIs). The mRNA-1273 vaccine was well-tolerated in a real-world setting, with 98% of respondents reporting local and systemic adverse events on day 1 after the second dose.
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