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Safety of BA.4-5 or BA.1 bivalent mRNA booster vaccines: nationwide cohort study

Objective To examine the association between the omicron adapted bivalent mRNA covid-19 booster vaccines received as a fourth dose and risk of adverse events.

Design Nationwide cohort study.

Setting Denmark.

Participants 2 225 567 adults aged ≥50 years who received three covid-19 vaccine doses during the study period, 1 January 2021 to 10 December 2022.

Main outcome measures The main outcome measure was rates of hospital visits for 27 different adverse events in a 28 day main risk period after vaccination with a bivalent omicron adapted mRNA booster vaccine as a fourth dose compared with reference period rates from day 29 after the third or fourth vaccine dose and onward.

Results 1 740 417 adults (mean age 67.8 years, standard deviation 10.7 years) received a bivalent mRNA vaccine as a fourth dose. Fourth dose vaccination with a bivalent mRNA vaccine was not associated with a statistically significant increased rate of any of the 27 adverse ....

Anders Hviid , Emilia Myrup Thiesson , Drug Administration , Centers For Disease , Us Centers For Disease , Danish Ministry Of Health , Danish Health , Niklas Worm Andersson , Myrup Thiesson , Disease Control , Vaccine Adverse Event Reporting System , Safety Datalink , Statens Serum Institut , Danish Ministry , Open Access , Creative Commons Attribution Non Commercial ,