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Association between mRNA COVID-19 vaccine boosters and mortality in Japan: The VENUS study

Wataru Mimura1, Chieko Ishiguro1, Megumi Maeda2

  • 1Section of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.

Human Vaccines & Immunotherapeutics
|May 17, 2024
PubMed

Insights

COVID-19 mRNA vaccine booster doses were evaluated for mortality risk. The study found no increased mortality risk associated with these booster doses in adults, supporting vaccine confidence.

Area of Science:

  • Immunology
  • Public Health
  • Epidemiology

Background:

  • Previous research indicated no increased mortality risk following primary COVID-19 mRNA vaccine series.
  • Limited data existed on the safety of COVID-19 mRNA vaccine booster doses regarding mortality.

Purpose of the Study:

  • To assess the mortality risk associated with mRNA vaccine booster doses in addition to the primary vaccination series.
  • To provide evidence for public health policy and address vaccine hesitancy.

Main Methods:

  • A nested case-control study design was employed, utilizing two age-specific cohorts (18-64 and ≥65 years).
  • Deaths were identified and matched with five controls per case based on municipality, age, and sex.
  • Conditional logistic regression analysis estimated adjusted odds ratios (aORs) for mRNA vaccine doses (1st-5th) compared to unvaccinated individuals within 21 and 42 days.

Main Results:

  • In the 18-64 years cohort, aORs for the 3rd and 4th doses within 0-21 days were 0.62 (95% CI: 0.24, 1.62) and 0.38 (95% CI: 0.08, 1.84), respectively.
  • In the ≥65 years cohort, aORs for the 3rd, 4th, and 5th doses were 0.36 (95% CI: 0.31, 0.43), 0.30 (95% CI: 0.25, 0.37), and 0.26 (95% CI: 0.20, 0.33), respectively.
  • These results indicate no increased mortality risk following mRNA vaccine boosters in either age group.

Conclusions:

  • Booster doses of mRNA COVID-19 vaccines are not associated with an increased risk of mortality.
  • These findings can inform future vaccination campaigns and help mitigate vaccine hesitancy.
  • The study reinforces the safety profile of mRNA COVID-19 vaccines, including booster administrations.
Keywords:
COVID-19 vaccinemRNA vaccinemortalitynested case-control studyvaccine safety

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