2026-10-10T22:59:04Z https://api.figshare.com/v2/oai

oai:figshare.com:article/34030331 2026-09-30T06:40:03Z category_7 category_16 category_19 category_21 category_46 category_64 category_122 portal_87 item_type_6 month_year_09_2026

Real-world evaluation of 2023–2024 XBB.1.5 mRNA and protein-based COVID-19 vaccine reactogenicity from the randomized BEEHIVE trial Sarang K. Yoon (23885021) Andrew L. Phillips (12841757) Hongwei Zhao (62620) Feiyun Yan (25142183) Danli Chen (17330170) Yan Zhuang (115199) Matthew S. Thiese (10987241) Elizabeth A. K. Rowley (25142186) Jacob McKell (25142189) Adam Yates (425034) Joshua Griffin (25142192) Steph Battan-Wraith (25142195) Riley Campbell (25142198) Rebecca V. Fink (25142201) Jesse Williams (18224037) Nicole Green (8748150) Tyler Allison (25142204) Yue Zhang (30585) Sarah W. Ball (23118409) Seth Toback (4873846) Matthew D. Rousculp (13528531) German L. Ellsworth (25142207) Medicine Physiology Pharmacology Biotechnology Immunology Cancer Mental Health SARS-CoV-2 omicron XBB side effects surveillance <p>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 <i>P</i> < .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 <i>P</i> < .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.</p> 2026-09-30T06:40:03Z Text Journal contribution 10.6084/m9.figshare.34030331.v1 https://figshare.com/articles/journal_contribution/Real-world_evaluation_of_2023_2024_XBB_1_5_mRNA_and_protein-based_COVID-19_vaccine_reactogenicity_from_the_randomized_BEEHIVE_trial/34030331 CC BY-NC-ND 4.0