tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2026 Dec;22(1):2735182.
doi: 10.1080/21645515.2026.2735182. Epub 2026 Sep 29.
Sarang K Yoon 1 , Andrew L Phillips 1 , Hongwei Zhao 1 , Feiyun Yan 2 , Danli Chen 2 , Yan Zhuang 3 , Matthew S Thiese 1 , Elizabeth A K Rowley 3 , Jacob McKell 1 , Adam Yates 3 , Joshua Griffin 1 , Steph Battan-Wraith 3 , Riley Campbell 1 , Rebecca V Fink 3 , Jesse Williams 1 , Nicole Green 1 , Tyler Allison 1 , Yue Zhang 2 , Sarah W Ball 3 , Seth Toback 4 , Matthew D Rousculp 4 , German L Ellsworth 1
Affiliations Expand
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.
Keywords: SARS-CoV-2; XBB; omicron; side effects; surveillance.
. 2026 Dec;22(1):2735182.
doi: 10.1080/21645515.2026.2735182. Epub 2026 Sep 29.
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 1 , Andrew L Phillips 1 , Hongwei Zhao 1 , Feiyun Yan 2 , Danli Chen 2 , Yan Zhuang 3 , Matthew S Thiese 1 , Elizabeth A K Rowley 3 , Jacob McKell 1 , Adam Yates 3 , Joshua Griffin 1 , Steph Battan-Wraith 3 , Riley Campbell 1 , Rebecca V Fink 3 , Jesse Williams 1 , Nicole Green 1 , Tyler Allison 1 , Yue Zhang 2 , Sarah W Ball 3 , Seth Toback 4 , Matthew D Rousculp 4 , German L Ellsworth 1
Affiliations Expand
- PMID: 42811742
- DOI: 10.1080/21645515.2026.2735182
Abstract
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.
Keywords: SARS-CoV-2; XBB; omicron; side effects; surveillance.