Real-world evaluation of 2023-2024 XBB.1.5 mRNA and protein-based COVID-19 vaccine reactogenicity from the randomized BEEHIVE trial.
The objective of this analysis was to assess reactogenicity profile differences between a protein- and mRNA-based COVID-19 vaccine in participants who had previously received ≥2 doses of an mRNA-based vaccine in a real-world, double-blinded, randomized, controlled trial. In the BEEHIVE/NCT06065176 trial (ClinicalTrials.gov: NCT06065176), participants randomized 1:1 received one dose of the Novavax (NVX) or Pfizer-BioNTech (PFZ) COVID-19 vaccine 2023-2024 formulation (XBB.1.5); a comparator group did not receive a dose. Electronic surveys collected solicited systemic (fatigue, fever, headache, joint pain, malaise/feeling sick, muscle pain, and nausea/vomiting) and local (injection-site pain, tenderness, and swelling) events on days 1, 2, and 6 after study vaccination. Significantly lower proportions of participants in the NVX (n = 448) vs. PFZ (n = 453) group reported a systemic (62.1% vs. 75.7%; risk difference -13.7%, 95% CI: -19.6% to -7.7%) or local (81.0% vs. 92.7%; risk difference -11.7%, 95% CI: -16.0% to -7.3%) event in the day-1 survey (both Cochran-Mantel-Haenszel P < .0001). Most events were mild. Reactogenicity rates decreased throughout the week; >80% and >94% of participants in either group reported no systemic or local reactogenicity, respectively, in the day-6 survey. Mean number of events/person were significantly lower for the NVX vs. PFZ group in the day-1 (systemic and local) and day-2 (local) surveys (each P < .0001). There were significant differences in reactogenicity profiles for the 2023-2024 formulations of the NVX and PFZ COVID-19 vaccines, with NVX consistently associated with lower reactogenicity rates than PFZ.
Authors
Yoon Yoon, Phillips Phillips, Zhao Zhao, Yan Yan, Chen Chen, Zhuang Zhuang, Thiese Thiese, Rowley Rowley, McKell McKell, Yates Yates, Griffin Griffin, Battan-Wraith Battan-Wraith, Campbell Campbell, Fink Fink, Williams Williams, Green Green, Allison Allison, Zhang Zhang, Ball Ball, Toback Toback, Rousculp Rousculp, Ellsworth Ellsworth
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