Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines

• DOI: 10.1001/jamanetworkopen.2024.43166
• Publication Date: 2024-11-06T16:00:56Z
• Authors: Emmanuel B. Walter; Elizabeth P. Schl...; Kawsar R. Talaat; Wes Rountree; Karen R. Broder; Jonathan Duffy; Lisa A. Grohskopf; Marek S. Poniewie...; Rachel L. Spreng; Mary A. Staat; Rediet Tekalign; Oidda Museru; Anju Goel; Grace N. Davis; Kenneth E. Schmader
• Keywords: Reactogenicity; myalgia

Importance Limited randomized clinical trial data exist on the safety of simultaneous administration COVID-19 and influenza vaccines. Objective To compare reactogenicity, safety, changes in health-related quality life (HRQOL) after vs sequential receipt messenger RNA (mRNA) vaccine quadrivalent inactivated (IIV4). Design, Setting, Participants This randomized, placebo-controlled was conducted between October 8, 2021, June 14, 2023, at 3 US sites. were nonpregnant persons aged 5 years or older with intention receiving both mRNA Interventions Intramuscular opposite arms either IIV4 saline placebo simultaneously visit 1. Those who received 1 those to 2 weeks later 2. Main Outcomes Measures The primary composite reactogenicity outcome proportion participants fever, chills, myalgia, and/or arthralgia moderate greater severity within 7 days vaccination visits 2, using a 10% noninferiority margin. Secondary outcomes solicited events unsolicited adverse (AEs) for each separately HRQOL 1, assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. Serious AEs (SAEs) special interest (AESIs) 121 days. compared groups. Results A total 335 (mean [SD] age, 33.4 [15.1] years) (169 group 166 group); 211 (63.0%) female, 255 (76.1%) bivalent BNT162b2 vaccine. (25.6% [n = 43]) noninferior (31.3% 52]) (site-adjusted difference, –5.6 percentage points [pp]; 95% CI, −15.2 4.0 pp). Respective proportions similar (visit 40 [23.8%] 47 [28.3%]; [3.0%] 9 [5.4%]). No significant differences (21 [12.4%] 16 [9.6%]), SAEs (1 [0.6%] [0.6%]), AESIs (19 [11.2%] [5.4%]) observed groups, respectively. Among severe mean (SD) EQ-5D-5L Index score decreased from 0.92 (0.08) (0.09) prevaccination 0.81 0.82 (0.12) postvaccination. Conclusions Relevance In this assessing vaccines, comparable These findings support option these Trial Registration ClinicalTrials.gov Identifier: NCT05028361