Coronavirus Disease 19 (COVID-19) Vaccine Effectiveness Against Symptomatic Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection during Delta-Dominant and Omicron-Dominant Periods in Japan: A Multicenter Prospective Case-control Study (Factors Associated with SARS-CoV-2 Infection and the Effectiveness of COVID-19 Vaccines Study)

Takeshi Arashiro, Yuzo Arima, Hirokazu Muraoka, Akihiro Sato, Kunihiro Oba, Yuki Uehara, Hiroko Arioka, Hideki Yanai, Jin Kuramochi, Genei Ihara, Kumi Chubachi, Naoki Yanagisawa, Yoshito Nagura, Yasuyuki Kato, Akihiro Ueda, Akira Numata, Hideaki Kato, Koji Ishii, Takao Ooki, Hideaki OkaYusuke Nishida, Ashley Stucky, Chris Smith, Martin Hibberd, Koya Ariyoshi, Motoi Suzuki

Research output: Contribution to journalArticlepeer-review

27 Citations (Scopus)

Abstract

Background: Although several coronavirus disease 2019 (COVID-19) vaccines initially showed high efficacy, there have been concerns because of waning immunity and the emergence of variants with immune escape capacity. Methods: A test-negative design case-control study was conducted in 16 healthcare facilities in Japan during the Delta-dominant period (August-September 2021) and the Omicron-dominant period (January-March 2022). Vaccine effectiveness (VE) against symptomatic severe acute respiratory syndrome coronavirus 2 infection was calculated for 2 doses for the Delta-dominant period and 2 or 3 doses for the Omicron-dominant period compared with unvaccinated individuals. Results: The analysis included 5795 individuals with 2595 (44.8%) cases. Among vaccinees, 2242 (55.8%) received BNT162b2 and 1624 (40.4%) received messenger RNA (mRNA)-1273 at manufacturer-recommended intervals. During the Delta-dominant period, VE was 88% (95% confidence interval [CI], 82-93) 14 days to 3 months after dose 2 and 87% (95% CI, 38-97) 3 to 6 months after dose 2. During the Omicron-dominant period, VE was 56% (95% CI, 37-70) 14 days to 3 months since dose 2, 52% (95% CI, 40-62) 3 to 6 months after dose 2, 49% (95% CI, 34-61) 6+ months after dose 2, and 74% (95% CI, 62-83) 14+ days after dose 3. Restricting to individuals at high risk of severe COVID-19 and additional adjustment for preventive measures (ie, mask wearing/high-risk behaviors) yielded similar estimates, respectively. Conclusions: In Japan, where most are infection-naïve, and strict prevention measures are maintained regardless of vaccination status, 2-dose mRNA vaccines provided high protection against symptomatic infection during the Delta-dominant period and moderate protection during the Omicron-dominant period. Among individuals who received an mRNA booster dose, VE recovered to a high level.

Original languageEnglish
Pages (from-to)E108-E115
JournalClinical Infectious Diseases
Volume76
Issue number3
DOIs
Publication statusPublished - 01-02-2023
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

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