JAMA Network February 26, 2024
The monovalent Omicron XBB.1.5–containing COVID-19 mRNA vaccines were authorized in the US and Europe for use in autumn and winter 2023-2024.1,2 In Denmark, the XBB.1.5-containing vaccines were recommended as a fifth COVID-19 vaccine dose to individuals aged 65 years and older beginning October 1, 2023. However, data to support safety evaluations are lacking.
We investigated the association between the XBB.1.5-containing vaccine administered as a fifth COVID-19 vaccine dose and the risk of 28 adverse events.
A study cohort of all individuals in Denmark aged 65 and older who had received 4 COVID-19 vaccine doses was established by cross-linking nationwide health care and demography registers on an individual level. The study period was September 15, 2022 (ie, the national rollout date...
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