Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University

Kaho Okumura; Azusa Hara; Isa Inada; Daisuke Sugiyama; Takahiro Hoshino; Takahiro Yakoh; Hirokazu Yokoyama; Hisashi Urushihara

doi:10.3390/vaccines10091461

Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University

Vaccines (Basel). 2022 Sep 3;10(9):1461. doi: 10.3390/vaccines10091461.

Authors

Kaho Okumura^{1

2}, Azusa Hara¹, Isa Inada¹, Daisuke Sugiyama³, Takahiro Hoshino⁴, Takahiro Yakoh⁵, Hirokazu Yokoyama⁶, Hisashi Urushihara¹

Affiliations

¹ Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan.
² Toshimagaoka Girls Senior High School, 1-25-22 Ikebukuro Toshima-ku, Tokyo 170-0013, Japan.
³ Faculty of Nursing and Medical Care, Keio University, 4411 Endoh, Fujisawa 252-0883, Japan.
⁴ Faculty of Economics, Keio University, 2-15-45 Mita, Minato-ku, Tokyo 108-8345, Japan.
⁵ Faculty of Science and Technology, Keio University, 3-14-1 Hiyoshi, Kohoku-ku, Yokohama 223-8522, Japan.
⁶ Health Center, Keio University, 2-15-45 Mita, Minato-ku, Tokyo 108-8345, Japan.

Abstract

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.

Keywords: Japan; mRNA vaccines; real world; real-time; vaccine safety.

Grants and funding

This research was conducted independently from external funding sources. Publication of this research was supported by the fund from the Global Science Campus (GSC) program [Japan Science and Technology Agency (JST) and Keio University]. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.