COVID-19 vaccine effectiveness against severe COVID-19 requiring oxygen therapy, invasive mechanical ventilation, and death in Japan: A multicenter case-control study (MOTIVATE study).
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Arashiro Takeshi, Miwa Maki, Nakagawa Hidenori, Takamatsu Junpei, Oba Kunihiro, Fujimi Satoshi, Kikuchi Hitoshi, Iwasawa Takamasa, Kanbe Fumiko, Oyama Keisuke, Kanai Masayuki, Ogata Yoshitaka, Asakura Takanori, Asami Takahiro, Mizuno Keiko, Sugita Manabu, Jinta Torahiko, Nishida Yusuke, Kato Hideaki, Atagi Kazuaki, Higaki Taiki, Nakano Yoshio, Tsutsumi Takeya, Doi Kent, Okugawa Shu, Ueda Akihiro, Nakamura Akira, Yoshida Toru, Shimada-Sammori Kaoru, Shimizu Keiki, Fujita Yasuo, Okochi Yasumi, Tochitani Kentaro, Nakanishi Asuka, Rinka Hiroshi, Taniyama Daisuke, Yamaguchi Asase, Uchikura Toshio, Matsunaga Maiko, Aono Hiromi, Hamaguchi Masanari, Motoda Kentaro, Nakayama Sohei, Yamamoto Kei, Oka Hideaki, Tanaka Katsushi, Inoue Takeshi, Kobayashi Mieko, Fujitani Shigeki, Tsukahara Maki, Takeda Saki, Stucky Ashley, Suzuki Tadaki, Smith Chris, Hibberd Martin, Ariyoshi Koya, Fujino Yuji, Arima Yuzo, Takeda Shinhiro, Hashimoto Satoru, Suzuki Motoi
Аннотация
METHODS: A case-control study was conducted in 24 hospitals in Japan for the Delta-dominant period (August-November 2021; "Delta") and early Omicron (BA.1/BA.2)-dominant period (January-June 2022; "Omicron"). Detailed chart review/interviews were conducted in January-May 2023. VE was measured using various outcomes including disease requiring oxygen therapy, disease requiring invasive mechanical ventilation (IMV), death, outcome restricting to "true" severe COVID-19 (where oxygen requirement is due to COVID-19 rather than another condition(s)), and progression from oxygen use to IMV or death among COVID-19 patients.
RESULTS: The analysis included 2125 individuals with respiratory failure (1608 cases [75.7%]; 99.2% of vaccinees received mRNA vaccines). During Delta, 2 doses provided high protection for up to 6 months (oxygen requirement: 95.2% [95% CI:88.7-98.0%] [restricted to "true" severe COVID-19: 95.5% {89.3-98.1%}]; IMV: 99.6% [97.3-99.9%]; fatal: 98.6% [92.3-99.7%]). During Omicron, 3 doses provided high protection for up to 6 months (oxygen requirement: 85.5% [68.8-93.3%] ["true" severe COVID-19: 88.1% {73.6-94.7%}]; IMV: 97.9% [85.9-99.7%]; fatal: 99.6% [95.2-99.97]). There was a trend towards higher VE for more severe and specific outcomes.
CONCLUSION: Multiple outcomes pointed towards high protection of 2 doses during Delta and 3 doses during Omicron. These results demonstrate the importance of using severe and specific outcomes to accurately measure VE against severe COVID-19, as recommended in WHO guidance in settings of intense transmission as seen during Omicron.